A philips representative became aware on 01 dec 2020 that a peripheral atherectomy procedure commenced on (b)(6) 2020 to treat a calcified lesion in the patient's mid superficial femoral artery (sfa).This procedure was part of a postmarket study conducted in (b)(6).The physician reportedly used a spectranetics turbo-tandem laser atherectomy catheter to treat the lesion.After the turbo-tandem was used, a dissection (grade e) was observed.A plain old balloon angioplasty (poba) (non-drug coated) was used to treat the dissection and with use of the balloon, the dissection improved from grade e to grade d.The procedure was completed, and the patient survived.There was no alleged malfunction of the turbo-tandem device in use during the procedure.This report is being conservatively submitted because it cannot be confirmed at this time whether the turbo-tandem device was being used in the area in which the dissection was observed.
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