The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.Reason for no return is pending.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During the procedure, a cat8 was advanced into a 8f sheath with no wire.Consequently, the cat8 became kinked upon advancing; therefore, the cat8 was removed and the procedure was completed using a new cat8.There was no report of an adverse effect to the patient.
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