平衡计分卡_bsc弹簧圈系列

BSC弹簧圈系列 BSC弹簧圈技术 可解脱弹簧圈 推送弹簧圈 0 018 0 035 0 018 0 035 Interlock 18 VortX 钻石 多环形 VortX 2DHelical Interlock 35 BSC弹簧圈系列 推送弹簧圈PushableCoils BSC推送弹簧圈 所有弹簧圈都是铂金圈所有的弹簧圈都有相同的基础制造流程 基础和二次缠绕所有都兼容MRI所有纤毛弹簧圈都含有Dacron 涤纶纤维所有微弹簧圈都需要通过弹簧圈推送器释放 弹簧圈适应范围 动静脉瘘 AVF动脉瘤外伤血管封堵 0 018 纤毛弹簧圈 复合Helical弹簧圈 0 018 纤毛弹簧圈 复合Helical弹簧圈 Features 0 018 纤毛弹簧圈 复合Helical弹簧圈 VORTX 0 018 钻石形弹簧圈 VORTX钻石形 2mm 3mm 2 5mm Apex Basis UL 2mm 4mm 4 0mm Apex Basis UL 2mm 5mm 5 5mm Apex Basis UL 2mm 6mm 6 5mm Apex Basis UL 尖端设计 外周栓塞 VortX18钻石形弹簧圈 0 018 推送弹簧圈 0 018 弹簧圈的释放 弹簧圈预置在塑料海波管中 安全轴芯将其锁定 移除安全轴芯然后推入海波管头端通过RHV 使其与输送系统 推送器 接头形成自然的贴合弹簧圈推送器 CoilPusher16 的硬头端用于将弹簧圈很好的推入输送系统中 至少进入30cm 然后撤出硬头端 使用软头端释放弹簧圈 035 纤毛铂金圈 035 纤毛铂金圈 VORTX35 Available2mm 4mmApex Basis3mm 5mmApex Basis3mm 6mmApex Basis3mm 7mmApex Basis 035 VortX纤毛铂金圈 035 弹簧圈的释放 弹簧圈预置在塑料海波管中 安全轴芯将其锁定 置入导管接头使用 035 038导丝的硬头端将弹簧圈推入导管中 使用正常的工作头端持续肝素冲洗导管 防止弹簧圈堵塞 BSCEmbolicAgents 可控弹簧圈 InterlockFiberedIDCOcclusionSystem Interlocking可控弹簧圈 铂金材料独特的InterlockingArm 互锁臂设计预装系统 直接输送Helical IDC 形状有18种尺寸 VotrX 纤毛IDC 有19种尺寸 直径从2mm到14mm Controlleddeployment在完全释放前 可以重新定位或回撤易于将弹簧圈预装系统过渡到微导管 Interlocking可控弹簧圈 Interlocking可控弹簧圈 Interlocking可控弹簧圈 Interlock FiberedIDC系统 ProductOffering 2D Multi Loop 3mmx6cm3mmx12cm4mmx8cm4mmx15cm5mmx8cm5mmx15cm6mmx10cm6mmx20cm8mmx20cm10mmx20cm10mmx30cm12mmx20cm12mmx30cm14mmx20cm14mmx30cmVortX DiamondCoil 2mm 3mmx2 3cm2mm 4mmx4 1cm2mm 5mmx5 8cm2mm 6mmx8 0cm Interlock FiberedIDC系统 推送弹簧圈的风险 移位 由于不恰当的弹簧圈长度和尺寸 导致不正确释放 推送弹簧圈的风险 输送导管的不稳定 导致的不正确释放 推送弹簧圈的风险 更好的精确性和控制与推送圈不同 InterlockingArms和输送导丝的设计允许在弹簧圈完全释放前可以回撤 提供更多的控制 而不仅仅是释放 Interlock OcclusionSystem ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved INTERLOCKINGARM 互锁臂作用加强机械分离可回撤设计弹簧圈在释放前保持锁定 InterlockFiberedIDCOcclusionSystem只用于外周血管的栓塞 不能用于神经血管的栓塞 Page10 更自信的栓塞铂金弹簧圈配合涤纶纤维 加速血栓形成 纤毛排列成流线束状 提高填塞效果 Interlock OcclusionSystem ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved FIBERBUNDLING流线方向优秀的密度和数量提高致填塞作用促血栓形成材料 输送鞘的渐细头端设计 减少过早的释放 弹簧圈打折货堵塞改善推送性 可靠的输送输送系统的渐细头端提供更可靠的输送 Page11 Interlock OcclusionSystem 增加手术的灵活性提供多种长度 直径和形状的弹簧圈 满足不同血管和手术的需求 Interlock FiberedIDCOcclusionSystem VORTX 18 VORTX 18钻石型纤毛铂金弹簧圈双尖端形状具有两个小头端 提高通过性和加速栓塞双尖端形状设计改善弹簧圈压缩两个小头端设计于闭塞中心血流 2DHELICAL纤毛弹簧圈远端直径为主要直径的75 1st1 5loops 帮助释放和减少创伤性锚定能力设计使得该弹簧圈成为理想的第一个弹簧圈 成栏技术 优秀的纤维束纤维束数量纤维束的位置20cm和30cm弹簧圈的近端纤维化 Interlock FiberedIDCOcclusionSystem 2DHELICAL 可控弹簧圈的优势 完全可控的释放可回撤 防止不充分释放或构型最小化误放的风险必要时可重新进入或重构优化弹簧圈的构型和获得理想填塞当尺寸不当时刻取出弹簧圈 尤其适用于邻近大动脉的病灶如重要动脉的假性动脉瘤 可控弹簧圈的优势 完全可控的释放多种选择 回撤 重新定位 再成形 交换 致密填塞 可控弹簧圈的优势 pullback 可控弹簧圈的优势 push densepacking 可控弹簧圈的优势 deliver 可控弹簧圈的适应证 可控弹簧圈的适应证 可控弹簧圈的适应证 突出 可控弹簧圈的适应证 导丝突出 回撤1 2cm 然后再推送 可控弹簧圈的适应证 可控弹簧圈的适应证 可控弹簧圈的适应证 医生对于Interlock临床应用的反馈 动脉瘤 假性动脉瘤 AVF AVM PAVM GIBleed 保护性 栓塞 GDA内漏 AAA外伤性出血脾脏 肝脏 肾脏盆腔 Interlock OcclusionSystem 可用在哪些手术 Confidential ForBostonScientificInternalUseOnly DoNotCopyorDistribute TheFiberedIDCOcclusionSystemisindicatedtoobstructorreducerateofbloodflowintheperipheralvasculature Thisdeviceisnotintendedforneurovascularuse Interlock OcclusionSystem 操作和释放要点 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved 一旦微导管到达需要栓塞的部位 注意保持微导管头端与血管方向平行 不能垂直于需要释放弹簧圈位置的血管壁 检查确认没有损伤并且互锁臂还处于锁定状态 轻轻的转动输送鞘安全锁定装置以解锁 两边同时转动 逆时针旋转近端2 3圈将输送系统推入微导管接头近端的鲁尔接头内开始持续的肝素化 通常 从加压包内持续的每1 3秒钟注入1滴 操作和释放要点 Page19 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved 打开RHV的螺钉 小心地将InterlockSystem推进 直到输送鞘的远端紧密的固定在微导管接头内 收紧RHV的螺钉防止逆流 但不要太紧 以免挤压到输送鞘而不能推送导丝 保持连续的灌注压力 平稳 连续地推进导丝 将弹簧圈和输送导丝从输送鞘推到微导管内 确保输送鞘保持在微导管接头内 以防弹簧圈过早的释放 一旦输送导丝近端露出部分不足10cm时 轻轻地回撤和移出输送鞘 不要丢掉输送鞘 以防在完全释放前需要回收弹簧圈 Page20 操作和释放要点 续上一页 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved 弹簧圈输送 1 微导管不透射线标记 在显影下推送弹簧圈直到互锁臂距离微导管远端的不透射线标记约1cm 如果需要重新定位 在显影下轻轻地收回 重新释放时 缓慢地推进导丝直到互锁臂越过微导管的远端不透射线标记 最后 将整个系统从微导管中移出 Page21 操作和释放要点 续上一页 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved 需要重点关注和考虑的因素 为了获得更好的栓塞并减少血栓并发症的风险 必须保证持续的肝素化当将输送鞘推至微导管接头中时 不要使用过大的力 输送鞘头端的变形会导致弹簧圈无法推出0 018 弹簧圈必须在显影下通过0 021 内径的微导管输送 且微导管必须有1 2个不透射线标记点 Page22 操作和释放要点 2个不透射线标记点的微导管 1个不透射线标记点的微导管 如果需要重新定位 轻轻地回撤 如果感觉难以重新定位 撤出并放弃该弹簧圈 轻轻地推送导丝直到互锁臂到达近端标记点 但先不要越过 如果越过近端标记点 互锁臂就已经处在微导管体外 然后解锁 Figure6 将互锁臂推至距离近端标记点约1cm处 Figure5 为防止过早的释放 在准备好释放前 不要再往前推送导丝 ManeuvertheInterlockSystemunderfluoroscopyuntilthecoildetachmentzoneisapproximately1cmproximaltothemicrocatheterradiopaquetipmarker Figure7 Thispositionstheinterlockingarmsapproximately1cmproximaltothemicrocathetertip IfInterlockSystemrepositioningisnecessary gentlyretracttheInterlockSystemunderfluoroscopy Ifrepositioningisdifficulttoimpossible removeanddiscardtheInterlockSystem seeInterlockSystemRemovalProcedureforfurtherinstructions Todeploythecoil slowlyadvancethedeliverywireunderfluoroscopyuntilinterlockingarmspassmicrocatheter stipmarker Figure8 Figure5 AdvancingInterlockOcclusionSystemtoPre ReleasePosition 2 ROmarkermicrocatheter Figure6 DeliveringInterlockOcclusionSystemcoil 2 ROmarkermicrocatheter Figure7 AdvancingInterlockOcclusionSystemtoPre ReleasePosition 1 ROmarkermicrocatheter Figure8 DeliveringInterlockOcclusionSystemcoil 1 ROmarkermicrocatheter Interlock OcclusionSystem 不透射线标记 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved RefertoInterlockFiberedIDCOcclusionSystemDirectionsforUseforcompleteinstructionsonhowtousethismedicaldevice Page23 Interlock OcclusionSystem ProductDimensions fromProximalEnd DeliveryWire 175cmIntroducerSheath 95cmDistalTaperedEnd 1 3cmOcclusionCoil MainDiameter RestrainedLength2DHelical3 14mm6 30cmVortX Diamond3 6mm2 3 8cm RemovingIntroducerSheath Gentlywithdrawandremovetheintroducersheathfromthemicrocatheteroncetheproximalendofthedeliverywireiswithin10cmoftheproximalendofthesheath DonotdiscardthesheathincaseitisnecessarytoremovetheInterlockSystempriortodeployment ProductDimensions IntroducerSheathRemoval ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved RefertoInterlockFiberedIDCOcclusionSystemDirectionsforUseforcompleteinstructionsonhowtousethismedicaldevice Page24 Interlock OcclusionSystem InordertoachieveexcellentperformanceoftheInterlockSystemandreducetheriskofthromboemboliccomplications itiscriticalthatacontinuousflowofappropriateflushsolutionbemaintainedbetweena themicrocatheterandguidingcatheter andb themicrocatheterandanyintraluminaldevice Continuousflushingmay Reduceretrogradebloodflowintothemicrocatheterandintroducersheathduringcoildelivery Reducecontrastcrystalformationand orthrombosisonthedeliverywireandintheguidingcatheterandmicrocatheterlumens Reduceprematurecoilthrombosis 持续冲洗 ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved StepstoBasicContinuousFlush refertoInterlockFiberedIDCOcclusionSystemDirectionsforUse AttachtheincludedRHVtotheproximallueradapteronthehubofthemicrocatheter Begincontinuousflowofanappropriateflushsolution Ingeneral onedropofflushsolutionevery1 3secondsfromapressurebagcontainingtheflushsolutionisrecommended OpenthethumbscrewoftheRHVandcarefullyinserttheInterlockSystemuntilthedistaltipoftheintroducersheathisfirmlyseatedinthemicrocatheterhub TightentheRHVthumbscrewjustenoughtopreventretrogradeflowbutnotsotightastopinchtheintroducersheathandinhibitforwardmovementofthedeliverywire Maintainin linepressureofthecontinuousflushtopreventretrogradeflowoncethesheathisremoved Page25 广泛的适应证完整的栓塞系统 Interlock OcclusionSystem ONCM980 06 06 2006BostonScientificCorporationoritsaffiliates Allrightsreserved 动脉瘤 假性动脉瘤AVF AVM 肺部AVMGIBleed保护性栓塞外伤精索静脉曲张 CompatibleRenegade MicrocatheterFathom Microguidewire Interlock 35FiberedIDC OcclusionSystem形状和尺寸 Interlock 35弹簧圈 立体3D设计允许forcircumfrentialwallapposition和良好包裹能力内脏血管动脉瘤 2D螺旋理想的锚定因为这个弹簧圈的结构经常保持与血管壁的接触 钻石闭塞能力源自首尾尖端的弹簧圈直径 最大截面阻塞 Interlock 35弹簧圈使用5Fr的ImagerII造影管释放 替代微导管 Interlock 35Coil立体形状 立体形状的弹簧圈用于提供圆周式的贴壁作用和出色的填充性能 适用于内脏血管瘤 适应证包括但不限于以下 脾动脉瘤肾动脉瘤髂内动脉栓塞AVM 2D螺旋形状弹簧圈用于提供优化的锚定能力 因为螺旋形状保证弹簧圈与直形或渐细血管壁的持续不变的接触和贴壁 适应证包括但不限于以下 精索静脉曲张栓塞盆腔淤血综合征栓塞胃十二指肠动脉栓塞近端脾动脉瘤栓塞 Interlock 35Coil2D螺旋形状 钻石形状弹簧圈设计用于提供最大化的闭塞作用 它具有渐细的近端和远端 最大化血流的阻断作用 适应证包括但不限于以下 精索静脉曲张栓塞盆腔淤血综合征栓塞内脏动脉瘤GIBleeds Interlock 35Coil钻石形状 注意事项弹簧圈直径如果选小了 就会产生移位 弹簧圈的选择取决于医生的偏好和临床情况 但通常都要求医生根据病灶的情况选择尺寸偏大的弹簧圈需要栓塞的血管形态和直径 以及邻近分支血管的情况 都会决定弹簧圈的直径和长度 Interlock 35Coil形状的选择 Interlock 35FiberedIDC OcclusionSystem互锁臂设计 Interlock35FiberedIDC OcclusionSystem通过简单的互锁将推送导丝和弹簧圈连接起来互锁连接是一种简单的连接 当互锁臂保持在输送系统内时 就会保持锁定状态 Interlock 35CoilInterlockingArms 互锁臂 注意事项 不要过快的回收 或顶着阻力回收 这可能导致弹簧圈拉伸或互锁臂损坏在输送过程中 不要旋转输送导丝超过一圈 360 过度的旋转会损坏输送系统或导致互锁臂在导管内的解脱 Interlock 35FiberedIDC OcclusionSystem纤毛 纤维特征 每个弹簧圈都含有许多致密涤纶纤维 它们可以结合血细胞并促进血栓形成涤纶纤维的特显 左图 显示纤毛的结构是有组织的 也有空隙 可快速形成血栓 Interlock 35CoilDacron Fiber 纤毛的作用 40cm长度的弹簧圈的纤毛总长度近6000cm每个弹簧圈的每个地方都有纤毛 Interlock 35CoilDacron Fiber 长度和密度 因为涤纶纤维的存在 合适流量的冲洗必须保持持续工作持续冲洗可以减少血液逆流至导管 减少造影剂结晶形成的风险 或弹簧圈及管腔内血块形成的可能通常 推荐从加压袋中每1 3秒钟注入1滴冲洗液 肝素化生理盐水 注意 持续冲洗过程中 确保不会有气体进入导管 Interlock 35CoilDacron Fiber 持续冲洗 0 021 012 IDof5FImagerIICatheter 0 045 还有将近3倍的空间存在让血液进入逆流导管内 Interlock 35Coil Interlock 18Coil 0 024 offreespace 0 009 offreespace IDofRenegade STCCatheter 0 021 ODofPlatinumCoilprimarywind Interlock Dacron Fiber 持续冲洗 Interlock 35FiberedIDC OcclusionSystem输送系统兼容性 Interlock 35弹簧圈需在显影下通过5F 0 035 0 89mm 或0 038 0 97mm 内腔 Imager II造影导管输送 Interlock 35Coil导管兼容性 PerDFU Note Physiciansshouldexercisetheirclinicaljudgmentinselectionanduseofcatheters BostonScientificCorporationprovidesnowarrantyforuseofthirdpartycatheterswithitsproducts Theuseofotherdiagnosticcathetersmayresultinaninabilitytodeliver deploy orrecapturethedevice 注意事项 切记不要使用柔软的导管输送Interlock 35 比如TerumoGlidecath Catheter 当使用柔软导管输送Interlock 35时 会感觉明显的阻力 基准测试测量通过导管推进弹簧圈时所需的力 LowerNumber LessForce 弹簧圈不能通过TerumoGlidecath Catheter 使用CookSlip Cath Catheter时 需要额外的力量推进 Interlock 35Coil导管兼容性 阻力测试 DataonfileatBostonScientific Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance TM 基准测试测量挤压导管时所需的力量 Lowernumber SofterCatheterTerumoGlidecath 是最柔软的 然后是CookSlip Cath Catheter 导管硬度的数据与摩擦力数据匹配 表明最柔软的导管即是在弹簧圈释放过程中阻力最大的导管 Interlock 35Coil导管兼容性 摩擦和柔软度 DataonfileatBostonScientific Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance 基准测试测量弯折导管时的弯曲半径 Lowernumber MoreKinkResistantAngiodynamicsSoft Vu 导管是最容易弯折的当导管弯折时 弹簧圈就无法往前推送 Interlock 35Coil导管兼容性 摩擦力和打折 DataonfileatBostonScientific Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance TM NoVoid Void Imager IICatheterImagerII导管显示了从导管接头到导管腔的平滑过渡平滑的过渡提高了弹簧圈从输送鞘到导管的过渡这种特性是生产过程中的严格监督和检查决定的 CompetitiveCatheterCordisTempo 导管的测试结果显示 20 的导管其接头到管腔的过渡存在明显的空隙空隙的存在影响了弹簧圈从输送鞘到管腔的过渡 ImagespropertyofBostonScientific Interlock 35Coil导管兼容性 Hub的区别 Interlock 35弹簧圈导管兼容 ImagerII造影管是最佳选择 1 2 3 全线产品推荐 不要关注特定弹簧圈 让手术选择弹簧圈 犹豫时 使用0 018 精确 可解脱弹簧圈潜在的优势力度 浓密纤维和长度的贡献精度 多种形状 多种直径 018或035系列 038 使用0 038 ImagerII造影管开始手术035 如果诊断性造影管已导入 请使用0 035 弹簧圈018 如果未提前建立通路 使用STC微导管和0 018 弹簧圈 同轴定位 5Fr造影管 微导管 定位轻松填充 5Fr造影管更易填实PE成篮 PE成篮 易处多 Interlock 35 3个原则 Interlock 35CoilandInterlock18CoilWhataretheDifferences 直径 长度 形状 输送导丝 ProductGuide Interlock 18Coil Interlock 35Coil 弹簧圈 纤毛 导管兼容性 填充性能 输送性能 致血栓性能 锚定性能 产品特性 Interlock 018Coil Interlock 035Coil KeyInterlock 35CoilPoints 产品销售 035Focus GIVarices AVM Hypogastric Varicocele GIBleed GDA Splenic PCS Endoleaks 临床病例 Interlock 35CoilClinicalSuccessExample AngiogramofLarge 3cm SplenicArteryAneurysmlocatedintheproximalthirdofSplenicArtery 1 1 Along angled6FCookSheathwasplacedattheoriginoftheCeliacartery 2 2 AC2CookBeacon TipCatheterwasusedtoobtainaselectiveangiogramofthesplenicartery 3 A0 035 Glidewire Guidewirewasadvanceddistaltotheaneurysm 4 TheBeaconTipCatheterwasremovedandaGlideCath Catheterwaspushedoverthewiredistaltotheaneurysm 3 4 5 TheGlidewireGuidewireandGlideCathCathetercombinationwasadvancedasfardistallyaspossible 5 6 The6Fsheathwasadvancedintotheproximalsplenicartery justproximaltotheoriginoftheaneurysm 6 Interlock 35CoilClinicalSuccessExample CoilNestindistalsplenicartery occludingtheoutflowfromalarge 3cmaneurysm 1 1 TheGlideCath Catheterwasremovedanda5FImager IIBERNwaspushedoverthewireintothedistalsplenicvasculature 2 2 FourInterlock35Coils two10 x20 two12x202D wereplacedwithinandjustproximaltothefirstmajorturninthedistalsplenicartery Continuousflushwasutilizedandnofrictionwasencountered 3 AnumberofshortpushablecoilsweresquirtedintothescaffoldingcreatedbytheInterlockCoils Pushablecoilswerechosenbecauseofthehosptial slackofinventoryofInterlock 35Coil 4 ThefinaltwounitsofInterlock 35Coils 12x40 thatthehospitalhadwereusedtolooselypacktheaneurysmsac 3 4 Interlock 35CoilClinicalSuccessExample 1 1 WithnoInterlock 35Coilsavailable theaccountdeterminedthatthe6FsheathwouldbeadequatetoplaceanAmplatzer IIVascularPlug 2 2 Althoughthevesseldiameterwasmeasuredtobe8mm thelargest6FcompatiblePlugthatwasontheshelfwasa10mmdiameter NOTE TheAmplatzerIIVascularPlugshouldbeoversizedby30 50 3 WhentheAmplatzerIIVascularPlugwasinitiallydeployed difficultywasencountereddetachingit asitrequiresadequatewallappositiontounscrew 4 Afteranumberofattempts theplugdiddetach butdidverylittletodisruptflowintotheaneurysm 3 4 CoilNestindistalsplenicartery occludingtheoutflowfromalarge 3cmaneurysm Interlock 35CoilClinicalSuccessExample Finalangiogramofcompletedembolizationofsplenicarteryaneurysm 1 1 Asaresultofpersistantforwardflow theAmplatzer IIVascularPlugwasusedasadistalbackstopforadditionalfiberedcoils 2 2 Anadditionaleight0 035 fiberedplatinumpushablecoilswereinjectedintotheproximalinflow 3 Followingdeploymentoftheadditionalcoils forwardflowwasstoppedwithintheaneurysmsacandbeyondthedistaloutflow 4 Arterialflowwasdivertedaroundtheproximalsplenicaneurysmandintotheparcreaticvascualtureabove 3 4 AbbreviatedStatements Interlock 35FiberedIDC OcclusionSystemCAUTION Federallaw USA restrictsthisdevicetosalebyorontheorderofaphysician INTENDEDUSE INDICATIONSFORUSE TheInterlock 35FiberedIDCOcclusionSystemisamodifiedinterlockingdetachablecoilindicatedtoobstructorreducerateofbloodflowintheperipheralvasculature Thisdeviceisnotintendedforneurovascularuse CONTRAINDICATIONS Noneknown WARNING CompatibilitywithMagneticResonanceImaging MRI hasnotbeenestablished andthedegreeofimagingdistortionresultingfromthecoilhasnotbeenmeasured ADVERSEEVENTS Complicationsrelatedtocatheterization e g hematomaatthesiteofentry clotformationatthetipofthecatheterandsubsequentdislodgement nerveandvesseldissectionorperforation Pain Hemorrhage Infectionnecessitatingmedicalintervention Foreignbodyreactionsnecessitatingmedicalintervention Emboli Ischemia Vasospasm Tissuenecrosis Undesirableclotformationofthevasculature Claudication Recanalization Death Temporaryneurologicaldeficit Priortouse pleaseseethecomplete DirectionsforUse formoreinformationonIndications Contraindications Warnings precautions Adverseeventsandoperatorsinstructions IMAGER IIANGIOGRAPHICCATHETERDEVICEDESCRIPTION TheImagerIIAngiographicCathetersaresterile single usediagnosticintravascularcatheters Thesecathetersareavailableinavarietyofflushandselectiveshapeswithlengthsof40cm 65cm 90cmand100cm Thedistalsegmentofthecatheterisradiopaquetoaidinvisualizationofthedeviceunderfluoroscopy Clinically flushcathetersareusedtodeliverabolusofcontrasttoapatientwhenobtaininganimageofalargearea aorta legrunoff etc Sideholesarealsoaddedtodispersethecontrast Selectivecathetersareusedtocreateimagesofspecificareasofinterest INTENDEDUSE INDICATIONSFORUSE TheImagerIIAngiographicCathetersaredesignedtoprovideapathwayfordeliveringcontrastmediatoselectedsitesinthevascularsystem includingthecarotidarteries CONTRAINDICATIONS Noknowncontraindications WARNINGS Angiographiccathetersaredesignedforusebyphysiciansengagedinthepracticeofaspecializedbranchofmedicine Useofthesedevicesshouldberestrictedtothosespecialiststrainedtoperformtheprocedure Athoroughunderstandingofthetechnicalprinciples clinicalapplicationsandrisksassociatedwithdiagnosticangiographyisnecessarybeforeperformingthisprocedure Accordingly theImagerIIAngiographicCathetersshouldonlybeusedbyphysicianswithathoroughunderstandingofangiographicprocedures Duetothevarioussizesandshapes andtherelativestiffnessofangiographiccatheters extremecaremustbetakenwhenselectingandusingtheImagerIIAngiographicCatheterstoavoiddamagetothevesselwallsthroughwhichthiscatheterpasses ContentssuppliedSTERILEusinganethyleneoxide EO process Donotuseifsterilebarrierisdamaged Ifdamageisfound callyourBostonScientificrepresentative Forsinglepatientuseonly Donotreuse reprocessorresterilize Reuse reprocessingorresterilizationmaycompromisethestructuralintegrityofthedeviceand orleadtodevicefailure which inturn mayresultinpatientinjury illnessordeath Reuse reprocessingorresterilizationmayalsocreateariskofcontaminationofthedeviceand orcausepatientinfectionorcross infection including butnotlimitedto thetransmissionofinfectiousdisease s fromonepatienttoanother Contaminationofthedevicemayleadtoinjury illnessordeathofthepatient Afteruse disposeofproductandpackaginginaccordancewithhospital administrativeand orlocalgovernmentpolicy Donotexceedthepressureratingsprintedonthedevicelabeling Catheterintegritymaybecompromisedifpressurelimitsareexceeded TheriskassociatedwithImagerIIAngiographicCathetersoutsidetheintendeduseisnotknown PRECAUTIONS Carefullyinspectthecatheterpriortousetoverifythatthesizeandshapearesuitableforthespecifiedprocedureandthatnodamagehasoccurredduringshipment ExtremecaremustbetakenwhenselectingandusingtheImagerIIAngiographicCatheterstoavoiddamagetothevesselwallsthroughwhichthiscatheterpasses Donotuseope