Model Number 22438-19 |
Device Problems
Retraction Problem (1536); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a lesion located in the internal carotid artery that was moderately calcified, heavily tortuous and 75% stenosed.At the end of the procedure and during attempted retrieval of the nav6 embolic protection device, resistance was felt when pulling back the barewire filter delivery wire to the retrieval catheter and it was observed that the guide wire was kinked in the vessel.Due to the resistance and kink, the guiding catheter was used to retrieve the nav6 and complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.
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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 will be submitted with all relevant information.
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Manufacturer Narrative
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Visual was performed on the returned product.The retraction problem was unable to be confirmed 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 complaints reported from this lot.The investigation determined that the reported retraction problem was likely related to circumstances of the procedure.It is likely that barewire became kinked during use resulting in resistance while attempting to retract the filter into the retrieval catheter.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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