Catalog Number 1120250-23 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 05/15/2018 |
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.The device is expected to be returned for evaluation.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 during device unpackaging and prior to use, the hypotube shaft of the 2.5 x 23 mm xience alpine stent delivery system (sds) was fractured/separated.There was no patient involvement.The device was not used.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 of a device component was 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported detachment of a device component.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initial 30-day medwatch report, the following information was received: the shaft separated when trying to advance the stent delivery system onto the guide wire, before entering the patient.There was no resistance during advancement or during removal.There was no reported adverse patient effect or a clinically significant delay during the procedure.No additional information was provided.
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Search Alerts/Recalls
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