The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) of the left leg using an indigo system cat5 aspiration catheter (cat5) and an indigo system separator 5 (sep5).During the procedure, while attempting to advance the cat5 with the sep5 inside for the first pass, the physician experienced resistance and subsequently, the distal tip of the cat5 became kinked.Therefore, the physician was unable to advance or retract the sep5 and decided to remove the entire system and end the procedure at that point.Upon removal of sep5 from the cat5, it was observed that the sep5 was stretched due to the kinked cat5.There was no report of an adverse effect to the patient.
|
The indigo system separator 5 (sep5) core and platinum wires were fractured approximately 173.0 cm from the proximal end.Evaluation of the returned cat5 revealed it had multiple consecutive kinks in the distal shaft.This type of damage typically occurs due to repeated forceful advancement of the cat5 against resistance.The root cause of the initial resistance experienced by the physician could not be determined.Further evaluation revealed the sep5 core and platinum wires were fractured proximal to the bulb.This damage likely occurred due to forceful manipulation of the sep5 within the damaged cat5.Penumbra separators and catheters are inspected during in-process inspection and during quality inspection after manufacturing the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
|