(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4): incorrect anatomy the device was received.Investigation is not yet complete.A follow-up report will be submitted with all relevant information.
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It was reported that the procedure was performed to treat a moderately calcified distal peripheral leg vessel.A emboshield nav6 lg embolic protection system (eps) was advanced distal to the target lesion without issue and the procedure was performed.During the filter basket retrieval, anatomical resistance was met and therefore the filter basket could not be pulled into the retrieval catheter.The distal portion of the filter basket became distorted and the tip of the wire appeared to have an s-shape.The filter basket was ultimately retrieved from the patient anatomy without the retrieval catheter, and the procedure concluded.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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Device codes: 1494 labeled.(b)(4).Correction: device code 2017 was changed to 1494 - incorrect anatomy.Evaluation summary: visual inspections were performed on the returned device.Visual inspections were performed on the returned device.The reported difficulty to retrieve the delivery catheter and barewire was not able to be confirmed as they were not returned.The indications for use section of the emboshield nav 6 instruction for use states: the emboshield nav6 embolic protection system is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries.In this case, it could not be determined if off-label use caused or contributed to the reported difficulties.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that anatomical conditions contributed to the reported difficulties; 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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