Catalog Number 1011710-38 |
Device Problems
Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/23/2014 |
Event Type
malfunction
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Event Description
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It was reported that the 3.5 x 38 mm xience prime stent delivery system (sds) was advanced, but could not cross to the lesion due to a burr [possible foreign material] in the distal portion of the stent.The sds was removed and a new sds was used successfully.There were no adverse patient effects and no clinically significant delay in the procedure.
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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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The reported foreign material present in device was unable to be confirmed.The reported difficulty removing the device was unable to be replicated in a testing environment as it was based on operational circumstances.Based on a visual and dimensional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/ review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.
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Search Alerts/Recalls
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