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 in the superior mesenteric artery (sma) using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician inserted another manufacturer's sheath with a removable valve into the patient.The physician then introduced the cat6 through the valve of the sheath using the peelable sheath and inadvertently crushed the tip of the cat6.Therefore, the cat6 was removed and the removable valve on the sheath was replaced with a large bore tuohy.The procedure was then successfully completed using a new cat6.There was no report of an adverse effect to the patient.
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