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 subclavian artery using indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, while advancing the cat8 into the sheath, the physician experienced resistance, and subsequently, the cat8 kinked near the hub; therefore, the cat8 was removed.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.
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