The patient's dob or age at time of event, weight, ethnicity, and race are unknown.Attempts to obtain the information has not been successful.During withdrawal, the angiosculpt device separated in two pieces.Additional intervention was performed, resulting in a prolonged procedure.Patient information regarding relevant tests/laboratory data, or medical history is unknown.Attempts to obtain the information has not been successful.The angiosculpt device was not returned and kept at the facility for internal investigations.Although no piece of the angiosculpt device was left in the patient, retained device component is listed in the ifu as a possible adverse effect of the procedure.
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The angiosculpt device was delivered to the lesion with no resistance.Using an endoflator, negatived air was applied and blood was observed on the endoflator.During removal, the proximal shaft separated inside the guide catheter; therefore, the device was removed as a unit.Rewiring of the lesion was required to complete the procedure with a new angiosculpt device.No patient injury reported.
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