A peripheral procedure commenced on (b)(6) 2020 to treat a severely calcified lesion in the mid superficial femoral artery (sfa).
This procedure was part of a postmarket study taking place in (b)(6), and a philips representative became aware of the event on 01 dec 2020.
The physician chose to use a spectranetics turbo-tandem laser atherectomy catheter to treat the lesion.
It was reported that after use of the turbo-tandem device, a dissection (grade a) was observed.
A plain old balloon angioplasty (poba) (non-drug coated) was used to treat the dissection, the procedure was completed, and the patient survived the procedure.
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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