Catalog Number 1120350-18 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2017 |
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 additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately tortuous mid circumflex artery.An unspecified guide wire was being advanced through a 3.5 x 18 mm xience alpine stent delivery system when the guide wire exited out the shaft instead of the guide wire exit notch.Another device was successfully used to complete the procedure.There was no clinically significant delay in 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 shaft tear was unable 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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported shaft tear as no tear was noted during returned device analysis.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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