The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system red72 reperfusion catheter (red72), a sendit delivery device (sendit), a benchmark bmx96 access system (bmx96), and a non-penumbra stent retriever.It should be noted that the patient''s anatomy was tortuous.During the procedure, the stent retriever along with the red72 was advanced to the target location and removed under aspiration three times without successful recanalization of the vessel.While attempting to remove the stent retriever and the red72 on the final attempt, the physician experienced resistance and noticed that the stent retriever and the red72 were fractured.It was reported that the red72 fractured at the distal end.The physician then snared the red72.The fractured stent retriever was left in the body after multiple attempts to remove.The procedure ended at this point.
|
Evaluation of the returned red72 confirmed a fracture on the distal end and revealed stretching at the fracture site.This type of damage typically occurs due to retraction against resistance.If the red72 is retracted against resistance, it may become stretched and subsequently fracture.The reported tortuous patient''s anatomy may have contributed to the resistance during retraction.Further evaluation of the device revealed multiple kinks both distal and proximal to the fractured location.This damage was likely incidental to the complaint.The kinks distal to the fractured location may have occurred due to advancement against resistance.The kinks proximal to the fractured location likely occurred during packaging for return to penumbra or snaring for removal.Penumbra 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.H3 other text : placeholder.
|