Catalog Number 1125350-23 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
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 was received.Investigation is not yet complete.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 a procedure of the left main without calcification or tortuousity, the lesion was pre-dilatated with a 3.5 nc trek balloon.An alpine stent was being deployed at 18 atmosphere (atm) when the balloon ruptured at the distal end.Post-dilatation was performed and the procedure completed without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.Visual inspections and scanning electron microscopy (sem) analysis were performed on the returned device.The balloon rupture 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 other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture.Based on the information reviewed, 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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