Catalog Number 1070350-38 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Internal file number - (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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Event Description
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It was reported that the shaft of a 3.5x38mm xience xpedition stent delivery system separated after removal of the protective sheath.The sds was not used in the patient.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned for analysis.The reported detachment was able to be confirmed.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 similar incidents from this lot.As there was contrast in the inflation lumen consistent with preparation, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during unpackaging and/or during preparation for use resulted in the noted hypotube bend and ultimately resulted in the reported hypotube detachment.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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