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 tibial vessels using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the physician completed one pass using the cat6.Then, while handling the cat6, the physician kinked the distal tip of the cat6.Therefore, the cat6 was removed.The physician decided to abandon the thrombus aspiration and opted to balloon angioplasty using the same sheath.There was no report of an adverse effect to the patient.
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