The patient was undergoing a thrombectomy procedure in the right femoral and tibial arteries using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 7 (cat7), an indigo system catrx aspiration catheter (catrx), a 7fr non-penumbra sheath, and a 0.014¿ guidewire.During the procedure, the physician aspirated clot in the superficial femoral artery (sfa) using a cat7.Next, the physician decided to use a catrx for the smaller vessel of the tibial arteries.The physician then successfully completed two passes in the target vessel using the catrx and sheath.While advancing the catrx through the sheath over the guidewire through the guidewire lumen to the target vessel for the next pass, the physician experienced resistance and the sheath prolapsed into the aorta.Subsequently, the physician pulled the catrx and sheath back and attempted to advance the catrx up and over to the target vessel; however, the physician experienced resistance and broke the catrx at the distal end.Upon removal of the catrx, the distal 30 cm to 40 cm of the catheter was noticed to still be on the guidewire inside the sheath.Therefore, the physician slowly removed the guidewire with the broken piece of the catrx from the sheath.The procedure was completed by performing balloon angioplasty in the tibial arteries.There was no report of an adverse effect to the patient.
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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.
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