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.This report is associated with mfr report number: 3005168196-2018-01037.
|
During preparation for a thrombectomy procedure, the indigo system separator d (sepd) and the indigo system catd aspiration catheter (catd) were dropped on the floor while the sepd was loaded inside the catd.The reported issue was found prior to use and therefore, the sepd and the catd were not used in the procedure.The procedure was completed using a new device.
|