The patient's dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.During withdrawal, the angiosculpt device separated in two pieces.Surgical intervention was required to remove from the patient.No piece of the angiosculpt device was retained in the patient.Foreign - (b)(6).The angiosculpt device was returned with just the proximal portion of the catheter measuring at 111 cm (core wire, proximal bond, proximal shaft, hypotube, hypotube bond, strain relief, and hub).The device separated proximal to the rx port.The core wire was intact and exposed beyond the proximal shaft.Per specification, approximately 26 cm of the distal assembly was not returned (distal tip, distal bond, balloon, marker bands, scoring element, intermediate bond, and transition tubing).Based on the complaint details, the angiosculpt device got stuck on the lesion.It is likely that some degree of force was applied by the user, resulting in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
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The angiosculpt device was inflated and deflated with no issues in the proximal lad.During withdrawal, resistance was noted and the device was unable to be removed from the lesion.When the physician tried to pull it out, the device snapped in two pieces.As a result, cabg was performed to retrieve the distal portion of the device.No piece of the device was retained in the patient.
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