Catalog Number 1012449-12 |
Device Problems
Kinked (1339); Difficult to Remove (1528)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/13/2017 |
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 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 when the nc trek balloon catheter was opened, the stylet was bent and it could not be removed from the balloon lumen.The device was not used and there was no patient involvement.There was no clinically significant delay to the intended procedure.No additional information was provided regarding this device issue.
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Manufacturer Narrative
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(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported kink and difficulty removing the stylet were 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 incidents from this lot.The investigation determined the reported difficulties were 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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