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.
|
While preparing an indigo system aspiration catheter 8 (cat8) on the back table for a thrombectomy procedure, the hospital staff inadvertently crushed the tip of the cat8.The tip of the cat8 became crushed prior to use and therefore, was not used in the procedure.The procedure was completed using a new cat8.
|