Catalog Number 1125400-12 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/22/2017 |
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 relevant information.
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Event Description
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It was reported that during preparation of the 4.0 x 12 mm xience alpine stent delivery system, air was noted coming back into the syringe.It was then noted that there was a crack in the hub.No difficulty was noted attaching the syringe to the hub.The device was not used, so there was no patient involvement.There was no reported clinically significant delay in procedure.A second same size xience alpine was used without issue.No additional information was provided.
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Manufacturer Narrative
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The patient and device codes were coded by the manufacturer.(b)(4).Evaluation summary: the device was returned for analysis.The reported cracked hub and hub leak were 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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported cracked hub.The hub leak; however, was likely a result of the cracked hub.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, additional information was received which indicated that the xience alpine was advancing in the guide catheter, when the air was noted in the syringe and the crack in the hub was noted.There was no adverse patient effect.No additional information was provided.
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Search Alerts/Recalls
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