The angiosculpt balloon was unable to deflate fully and got caught on the lesion.During retraction, resistance was noted and upon removal, the device separated.Additional intervention was required to remove from the patient and a competitor device was used to complete the procedure, thus resulting in prolongation of the case.No patient injury reported.(b)(4).The angiosculpt device was not returned for evaluation, thus no product investigation was performed.Per the ifu, retained device components is listed as a possible adverse effect of the procedure.
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