The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure to clean out a popliteal occlusion using an indigo system aspiration catheter 6 (cat6).Prior to the procedure, the physician stented a segment in the superficial femoral artery (sfa) of the patient.During the procedure, while the physician was attempting to advance the cat6 through another manufacturer's sheath, the cat6 became kinked.Therefore, the kinked cat6 was removed and the procedure was successfully completed using a new cat6 and another manufacturer's sheath.There was no report of an adverse effect to the patient.
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