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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The patient was undergoing a thrombectomy procedure in the right coronary artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra guide catheter.During the procedure, the physician experienced slight resistance while advancing the catrx through the guide catheter.The catrx was then advanced outside of the guide catheter towards the clot; however, nothing was aspirated and the catrx became stuck.As the catrx was pulled back into the guide catheter, the physician experienced resistance and the catrx broke in half while within the sheath, at the proximal end of the rapid exchange lumen.Therefore, the catrx and guide catheter were removed together.The physician completed the procedure by performing angioplasty and by using a stent.There was no report of an adverse effect to the patient.
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