BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 45007 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 08/23/2018 |
Event Type
Injury
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Event Description
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(b)(6) study.It was reported a dissection occurred.On (b)(6) 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.
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Event Description
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(b)(6) study.It was reported a dissection occurred.(b)(6) 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.It was further reported that an entirely specific stenting procedure was performed to treat the grade b dissection which occurred after the use of the jetstream devices, before further balloon and stenting occurred.
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Event Description
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Jetstream (b)(6) study.It was reported a dissection occurred.On (b)(6) 2018 - the index procedure was performed to treat a 71% stenosed target lesion with a reference vessel diameter of 5.0 mm, length of 50 mm and classified as a tasc ii, located in the left mid superficial femoral artery (sfa).The target lesion was successfully treated with the use of a jetstream xc 2.1/3.0 mm and a jetstream xc 2.4/3.4 catheter.It was noted that a grade b dissection occurred after using the jetstream catheters prior to ballooning and stenting.Intervention was performed to treat the event.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 0% final residual stenosis.The event was considered to be resolved.It was further reported that an entirely specific stenting procedure was performed to treat the grade b dissection which occurred after the use of the jetstream devices, before further balloon and stenting occurred.Device evaluated by mfr: the device and the catheter shaft were checked for damage.The device showed no damage.Functional testing revealed the device functioned as designed with no errors or issues.Inspection of the remainder of the device, revealed no other damage or irregularities.
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