The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and popliteal artery using an indigo system aspiration catheter 8 (cat8).It was noted that a stent that was previously placed in the patient became occluded with thrombus.During the procedure, the physician completed two passes using the cat8.However, the previously placed stent had collapsed slightly when aspiration was turned on.Subsequently, while turning the cat8 in the vessel, the physician noticed the tip of the cat8 became caught at the proximal end of the stent.Consequently, the distal radio-opaque marker band of the cat8 became unraveled and broke off within the patient.The cat8 was then removed and the physician decided to place another stent inside of the previously placed stent.It was also reported that by placing the additional stent, it trapped and secured the broken marker band of the cat8 in place.The procedure was completed using an indigo system aspiration catheter 6 (cat6).There was no report of an adverse effect to the patient.
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Evaluation of the returned cat8 confirmed that the marker band was detached from the device.Further evaluation of the device revealed that the distal tip was damaged.Based on the reported complaint, this damage was likely a result of manipulation the device while the tip of the device was caught at the proximal end of the stent.This distal tip damage likely contributed to the marker band detaching from the device during the procedure.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.
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