A peripheral atherectomy procedure commenced to treat a lesion in the distal tibial artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.The report stated that the physician had pedal access to the lesion, as well as access from above.He advanced the turbo elite device from above while holding fairly aggressive back pressure as he attempted to cross the lesion.A few different settings on the turbo elite device were used to attempt to cross the lesion, but were unsuccessful.As the physician was trying to advance the laser, the outer jacket reportedly started to wrinkle and it seemed the device was having a hard time tracking, or possibly getting stuck on the wire, which was a 14 command wire.The philips representative advised the physician to stop and withdraw the turbo elite device from the patient.He was then able to cross the lesion via balloon angioplasty from the pedal access, and the procedure was completed with no reported patient harm.The physician stated he didn't believe the device was defective; he stated he was just being pretty rough with it.The philips representative stated that the catheter had wrinkles present, along with a tear in the device's outer jacket with exposed fibers.She was unsure if the device was also manipulated by the physician and/or tech after it was removed from the patient.This event is being reported due to unintended radiation exposure, potential for harm.
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