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 in the right coronary artery (rca) using an indigo system aspiration catheter 6 (cat6), indigo system catrx aspiration catheter (catrx), non-penumbra guide catheter and 0.014 guidewire.During the procedure, the cat6 with a guidewire was unable to advance past 5cm into the guide catheter, and the physician experienced resistance.Therefore, the cat6 was removed.It was reported that a peel away sheath was not used with the cat6.The physician then attempted to aspirate the thrombus using a catrx but was unsuccessful.The procedure ended at this point, and the patient will undergo surgery for vein graft.There was no report of an adverse effect to the patient.
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