The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra coils, a non-penumbra microcatheter and a non-penumbra micro-guide catheter.During the procedure, the physician successfully implanted the coils in the target vessel.While performing a series of contrast runs, the physician noticed that only a small amount of the contrast came out the benchmark and the imaging was a little less cloudy than usual.The physician suspected a leak and decided to remove the benchmark.Subsequently, while retracting the benchmark, the distal end of the benchmark fractured and unraveled in the brachial artery.Therefore, a vascular surgeon performed a surgical cut down to retrieve the fractured distal end of the benchmark from the brachial artery.It was also reported that the benchmark might have been damaged at the beginning of the procedure.The procedure ended at this point.There was no report of an adverse effect to the patient.
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Evaluation of the returned benchmark confirmed that the catheter was fractured near the distal end.This damage typically occurs due to retraction against resistance.Based on the reported complaint, it is unknown if resistance was experienced.Further evaluation revealed multiple kinks along the catheter shaft and on the distal tip.Stretching was also found on the distal fractured segment.The kinks on the distal tip may have contributed to the small amount of contrast coming out of the benchmark during the procedure and maybe the reported damage at the beginning of the procedure.Several of these kinks were likely incidental and may have occurred post-procedure.Evaluation also revealed a cut on the distal tip.The cut likely occurred during surgical cut down to retrieve the distal fractured segment and was incidental to the complaint.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.
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