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 patient was undergoing a thrombectomy procedure using an indigo system cat 6 kit.During the procedure, the mid-shaft of the indigo system aspiration catheter 6 (cat6) unraveled; therefore, the cat6 was removed.The procedure was completed using another cat6.There was no report of an adverse effect to the patient.No further information is available.
|