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.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure using an indigo aspiration system catheter 6 (cat6).During the procedure, while attempting to advance a cat6 over a 0.18 guide wire through a sheath, the tip of the cat6 became kinked.It was reported that the rotating hemostasis valve of the sheath was too tight and the cat6 could not be advanced into it and therefore, it was removed.The procedure was completed using an indigo aspiration system catheter 5 (cat5) and the same sheath.There was no report of an adverse effect to the patient.
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