Model Number 112266-003 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism (1829); Pain (1994); Vascular Dissection (3160)
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Event Date 03/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
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Event Description
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Jetstream (b)(6) study.It was reported that the patient experienced an embolization and pain in the lower limb.The 100% stenosed, 5.0mmx90mm, tasc ii b target classified lesion was located in the right superficial femoral artery including ppa.The lesion was treated with a 2.4 mm jetstream xc atherectomy catheter.A distal embolization of the target limb was detected through angiography in the arterial peroneal."interlayer" was noted and pain was experienced in the right lower limb.Post treatment, percutaneous transluminal balloon angioplasty (pta) was not performed and final stenosis was not measured.The subject was discharged with aspirin and clopidogrel.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that during the procedure, a dissection was noted.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the distal embolization of target limb is no longer related to the jetstream console and the pain in the right lower limb is no longer related to the jetstream xc atherectomy catheter.It was further confirmed that no dissection occurred.
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Search Alerts/Recalls
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