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.
|
During preparation for a thrombectomy procedure, the hospital technician inadvertently kinked the indigo system aspiration catheter 6 (cat6).The cat6 was damaged prior to use and therefore, it was not used in the procedure.The procedure was completed using a new cat6.
|