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 radial and ulnar artery using an indigo system cat rx kit.During the procedure, while attempting to advance an indigo system catrx aspiration catheter (catrx) through a non-penumbra sheath, the catrx bent at the junction where the catrx rapid exchange port ends; therefore, the catrx was removed.The procedure was completed using an indigo system aspiration catheter 6 (cat6) and the same sheath.There was no report of an adverse effect to the patient.
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