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.
|
The patient was undergoing a coil embolization procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 over a 0.35 wire and attempted to insert the cat6 into the sheath.However, while attempting to advance the cat6 through the hub of the sheath, it became kinked; therefore, the cat6 was removed.Upon inspecting the sheath, the physician noticed that it was a 6f guide instead of a 6f sheath; it was reported that the 6f guide catheter valve was too small for the cat6 and hence the crushing of the cat6.The 6f guide catheter was then removed and the procedure was completed using a 8f guide catheter and a new cat6.There was no report of an adverse effect to the patient.
|