A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the mid posterior tibial (pt) artery.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that the turbo elite device could not cross the lesion.When the device was removed from the patient, they noticed the back end of the catheter was melted and fibers exposed.Photo returned to the manufacturer confirmed the report.A.9 turbo elite device was used to complete the procedure with no reported patient harm.Based on the photos provided, this event is being reported for unintended radiation exposure, potential for harm.
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Patient's date of birth and age unk, patient's gender unk, patient's weight unk, patient's race/ethnicity unk, relevant tests/laboratory data unk, other relevant history unk.The device was discarded, thus no investigation could be completed.Photo provided to the manufacturer showed deformation and separation of the device's outer jacket, being held together by exposed fibers within the device.With no device evaluation possible, the cause of the failure cannot be established.
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