Catalog Number 1074350-12 |
Device Problems
Product Quality Problem (1506); Difficult to Advance (2920); Activation Failure (3270)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat an unknown lesion.The xience xpedition stent delivery system (sds) was sticking to the guide wire and there was difficulty deploying the stent in the lesion.The sds was switched to a non-abbott sds to complete the procedure.There were no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).If follow-up what type: correction: mfr site: reg #.Evaluation summary: the device was returned for analysis.The reported difficult to position, physical property issue and failure to deploy were not confirmed, as there was no stickiness noted and the stent deployed without issue.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a coagulation of blood and/or contrast on the guide wire resulted in the reported physical property issue (sds sticking to the guide wire); thus resulting in the reported difficulty to position and the reported failure to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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