Model Number 24657 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/30/2020 |
Event Type
malfunction
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Event Description
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It was reported that the catheter broke.A 6 x 100 x 130 eluvia self-expanding stent was selected for use.The stent was implanted in the superficial femoral artery (sfa) without incident.Upon removal of the stent delivery system from the patient, the catheter broke.The procedure was completed, and the patient condition post-procedure was reported as stable.
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Manufacturer Narrative
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B3: date of event was corrected from (b)(6) 2020 to (b)(6) 2020.Device evaluated by mfr: visual examination revealed multiple kinks to the outer sheath.The inner liner is kinked 75mm from the tip.The inner liner, proximal inner, and tip is separated from the device.Microscopic examination revealed no additional damages.The handle was open to verify how the inner liner separated from the clip.The cuff bond was found inside the handle.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the inner liner was pulled through the cuff bond.
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Event Description
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It was reported that the catheter broke.A 6x100x130 eluvia self-expanding stent was selected for use.The stent was implanted in the superficial femoral artery (sfa) without incident.Upon removal of the stent delivery system from the patient, the catheter broke.The procedure was completed, and the patient condition post-procedure was reported as stable.
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Search Alerts/Recalls
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