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 in the anterior tibial artery (at) using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician encountered resistance while advancing the cat6 and subsequently, the cat6 became twisted and ovalized at the distal end when the physician attempted to torque it.Therefore, the cat6 was removed.The procedure was completed using another cat6.There was no report of an adverse effect to the patient.
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