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 aspiration catheter 6 (cat6), aspiration tubing (tubing), and penumbra engine canister (canister).During the procedure, the cat6 was advanced over the guidewire and into the patient.Subsequently, the guidewire was removed, and the physician noticed that the cat6 was not aspirating after connecting to the tubing and canister.Therefore, the cat6 was removed.The procedure was completed using a new cat6, tubing and the same canister.There was no report of an adverse effect to the patient.
|