Patient's date of birth, age unk.Patient's gender unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was returned to the manufacturer on 22 feb 2022.The device evaluation and investigation were completed on 03 mar 2022.Device evaluation: the device was returned and evaluated by a cross functional team.No damage was seen to the device's tail tube.Kinks were seen on the device's working length at 14, 17 and 19 inches from the bifurcate.At 14 and 17 inches from the bifurcate, broken fibers and breaches to the outer jacket were visible.Approximately half of the fibers were dead at the device's distal tip and proximal coupler.Calibration was not attempted due to the breaches seen in the outer jacket.There were not enough biologics present on the device to determine if the device had entered the body.Based on the device evaluation and investigation, it could not be determined when or how the kinks, breaches and broken fibers occurred.
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A peripheral atherectomy procedure commenced, indication for procedure/location of procedure unk.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that the turbo elite device did not calibrate, so a second turbo elite device, same model, was used to successfully complete the procedure with no reported patient harm.However, during device evaluation on 03 mar 2022, it was discovered that kinks, broken fibers and breaches to the device's outer jacket were present on the device's working length.This report captures the turbo elite which was found to have kinks, broken fibers and breaches to the outer jacket, causing unintended radiation exposure, potential for harm.
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