Catalog Number 1012450-12 |
Device Problems
Detachment Of Device Component (1104); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/27/2017 |
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 the procedure was to treat a narrow and heavily calcified lesion in the distal left main (lm).The 3.25x12 nc trek balloon dilatation catheter (bdc) was advanced however failed to cross the lesion after several attempts due to the anatomy and the shaft separated.The nc trek was removed with the guiding catheter.A new balloon catheter was used to complete the procedure.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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Internal file number - (b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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