Model Number FUSION 6MM-40CM SUPP PERIPHERAL GRAFT |
Device Problem
Use of Device Problem (1670)
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Patient Problems
No Patient Involvement (2645); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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This is notice of a potential product quality complaint received during market research study 16755 conducted by incrowd.Reporter id: 16755 - 2045178 q4: (when performing anastomosis, does the thread glide through the graft with ease?)a: acceptable comment: sometimes the prosthesis is difficult to pierce no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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Trackwise # (b)(4).Analysis of production for ship history conducted: (3331/213/67) a lot history record review was completed for lots 25150268 and 25151894 the last 2 lots shipped prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Search Alerts/Recalls
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