Catalog Number 42045120-120 |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 the procedure was to treat a mildly tortuous, moderately calcified superficial femoral artery that was 50% stenosed.During loading of the supera self expanding stent system (sess) onto the non-abbott guide wire, the supera met resistance but ultimately the supera sess was loaded onto the guide wire.Then during advancement of the supera stent, resistance was also met and it became stuck with an unspecified source.It was ultimately able to be removed and replaced with another supera to successfully complete the procedure.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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The device was returned for analysis.The reported difficult to insert was able to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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.As there was no damage noted to the device during the inspection prior to use, 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 preparation for use resulted in the noted tip bend; thus resulting in the reported difficult to insert, difficult to advance and difficult to remove.Manipulation of the device likely resulted in the noted torn sheath.The noted shaft kink likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Search Alerts/Recalls
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