Catalog Number 1074300-33 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/20/2014 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of a 3.0 x 33 mm xience xpedition device, a tiny orange fleck of coating-like material, about 2 to 3 mm in size, fluttered out when the device was removed from the dispenser coil.It is unknown if the fleck of material came from the device or from the dispenser coil.The device was not used on the patient.The procedure was continued using a new xience xpedition device of the same size.There was no report of clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was received.Investigation is not yet complete.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 foreign material was unable to be confirmed.Based on a visual 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 electronic complaint database revealed no other similar incidents reported for foreign material from this lot.Based on the reviewed information, no product deficiency was identified.
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Search Alerts/Recalls
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