Catalog Number 1012272-12 |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was received.Investigation is not yet complete.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 a procedure of the chronic totally occluded, 100% stenosed, mid left anterior descending (lad) artery, the 2.5 x 12 mm trek balloon dilatation catheter (bdc) was being used when a shaft kink occurred.The device was removed with some resistance noted and a different trek bdc was used to complete the procedure.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: visual and dimensional inspections were performed on the returned device.The kink was confirmed.The difficulty removing the device 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 difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Search Alerts/Recalls
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