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.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician experienced resistance while inserting the cat6 into a 7f sheath and subsequently, the cat6 collapsed.The physician stated that the 7f sheath valve was tighter and very different; therefore, the cat6 was removed and the procedure was completed using a new cat6.There was no report of an adverse effect to the patient.
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