(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The product was not returned to abbott vascular for analysis.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 similar incidents reported from this lot.The emboshield nav6 embolic protection system instructions for use (ifu) states: the emboshield nav6 rapid exchange (rx) embolic protection system (eps) is designed to capture embolic material released during angioplasty and stent procedures within carotid arteries.The violation of the ifu does not appear to have contributed to the reported kinked retrieval catheter.It is likely that manipulation of the barewire and retrieval catheter, during retraction, likely resulted in the reported kinked retrieval catheter, causing the reported difficulty removing through the non-abbott introducer sheath.The investigation determined that the reported kinks and difficulty to remove appear to be related to circumstance of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The grand slam guide wire is filed under a separate medwatch report number.
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It was reported that on (b)(6) 2018, the patient underwent a peripheral procedure to treat a target lesion in the heavily calcified and tortuous iliac artery.The emboshield nav6 embolic protection device was placed for distal protection.The grand slam guide wire was placed subintimally.During use of a non-abbott reentry device, the reentry device needle pierced the guide wire and sheared off a portion of the guide wire.The separated guide wire portion remains in the patient anatomy.No attempt was made to remove the separated guide wire segment.The emboshield nav6 embolic protection device filter was pulled into the retrieval catheter without difficulty; however, during removal, the retrieval catheter kinked and was difficult to remove from the non-abbott introducer sheath.The introducer sheath and retrieval catheter were removed as a single unit.There was no adverse patient effect with regards to the emboshield nav6.No additional information was provided.
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