The patient's dob, age at time of event, or weight is unknown.During withdrawal the angiosculpt device got stuck on sharp calcium chuck.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.In addition, lab analysis confirmed a shaft separation.Patient information regarding relevant tests/laboratory data, or medical history is unknown.The angiosculpt device was returned in two pieces.The device separated at the intermediate shaft proximal to the rx port.The intermediate shaft was flattened from the rx port.The hypotube was kinked and the core wire was bent at the distal end and proximal end.Based on the lab analysis, it is probable the user applied excessive exertion of force to try and remove from the calcium, which resulted in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
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Patient had previously placed stents in left main and lad with significant in-stent restenosis.The vessel was highly calcified, with moderate tortuosity.The physician decided to treat with a 3.5 mm x 10 mm angiosculpt device.After inflating it twice, the balloon could not be removed and believed it got stuck on a sharp calcium chunk.The physician was able to get a guideliner to abut the angiosculpt scoring element and get a 3.5 mm x 30 mm non-compliant balloon distal to the angiosculpt balloon on a buddy wire to pull the balloon back into the guideliner.The patient experienced mild angina during removal, but otherwise was discharged the following day with good flow and no complications.
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