Catalog Number 1012449-12 |
Device Problems
Detachment Of Device Component (1104); Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Internal file number - (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 3.0x12 nc trek met no resistance advancing into the 6 french guide catheter, but the shaft of the nc trek separated and kinked.The shaft separated in the guide catheter and was removed with the guide catheter.A shorter, 3.0x8 nc trek was used to complete the procedure with a larger guide catheter.There were no adverse patient effects and no 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 inspection was performed on the returned device.The reported proximal shaft separation and kink were confirmed.The investigation determined the reported proximal shaft separation and kink appear to be related to circumstances of the procedure.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 of the reported lot did not indicate a lot specific quality issue related to proximal shaft separation or a kink.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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Event Description
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Additional information: the device was not prepped (air aspiration) prior to use.
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Search Alerts/Recalls
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