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 coil embolization procedure in the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), pod packing coils (pod pcs), a non-penumbra catheter.During the procedure, while inserting the lantern into the catheter the physician encountered resistance and subsequently, the lantern became kinked.The physician attempted to advance a pod pc through the lantern and was unable to; therefore, the pod pc was re-sheathed and the lantern was removed from the patient.The procedure was completed using a new lantern, the same pod pc, additional pod pcs, and the same catheter.There was no report of an adverse effect to the patient.
|