Model Number 1012451-15 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 11/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2019001.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 while opening the 3.5x15 mm nc trek balloon dilatation catheter (bdc), the shaft broke.The device was not used and there was no patient involvement.There was no clinically significant delay in the procedure.A new nc trek was used to continue the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported break was able to be 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 appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during unpackaging and/or during advancement onto the guide wire/use resulted in the noted device damages (kink, multiple bends) and ultimately resulted in the reported break/separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient code 2645 was removed.
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Event Description
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Additional information: returned device analysis identified that the device was inserted into the anatomy.No additional information was provided.
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Search Alerts/Recalls
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