Catalog Number 22443-19 |
Device Problems
Retraction Problem (1536); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 procedure was an atherectomy of the superficial femoral and popliteal arteries.The emboshield nav6 embolic protection system (eps) was used with the 315 cm barewire and a non-abbott atherectomy device.The procedure lasted about 45 minutes.Upon retrieval of the emboshield nav6 filter with the retrieval catheter, the retrieval catheter could not be pushed completely over the half full filter [when pulling back on the wire] but it was reportedly docked per the instructions for use.The half full filter kept slipping and then tore at the side when it was pulled back into the delivery catheter.Everything was able to be retrieved and the retrieval catheter and barewire were removed as a single unit; however, they were not stuck together and there was no resistance once the filter was retrieved.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Event Description
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It was reported that the procedure was an atherectomy of the superficial femoral and popliteal arteries.The emboshield nav6 embolic protection system (eps) was used with the 315 cm barewire and a non-abbott atherectomy device.The procedure lasted about 45 minutes.Upon retrieval of the emboshield nav6 filter with the retrieval catheter, the retrieval catheter could not be pushed completely over the half full filter [when pulling back on the wire] but it was reportedly docked per the instructions for use.The half full filter kept slipping and then tore at the side when it was pulled back into the retrieval catheter.Everything was able to be retrieved and the retrieval catheter and barewire were removed as a single unit; however, they were not stuck together and there was no resistance once the filter was retrieved.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.The barewire will be captured as a non-complaint product experience.The barewire was used and there were no device issues or patient effects associated with this device.There was confirmed to be no resistance during removal of the retrieval catheter and barewire once the filter was able to be retrieved.There is nothing in the information provided that meets any part of the definition for a complaint as stated in 21 cfr 820.3.
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Manufacturer Narrative
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Visual analysis was performed on the returned product.The retraction problem causing split to the retrieval catheter tip catheter was unable to be confirmed as the retrieval catheter was not returned.There was no damage noted to the filtration element.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 revealed no other similar incidents and/or complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the difficulty retrieving the filter into the retrieval catheter causing the tip of the retrieval catheter pod to split was due to a large embolic load preventing the filtration element from encapsulated into retrieval catheter pod, or possible bent tip of the retrieval catheter preventing the filter from pulling in; however, this could not be confirmed.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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