THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 414-151 |
Device Problem
Melted (1385)
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Patient Problem
Unintended Radiation Exposure (4565)
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Event Date 03/09/2022 |
Event Type
malfunction
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Event Description
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A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient''s proximal superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, the catheter started smoking; the guide wire became stuck in the turbo elite catheter as well and the entire system was removed.It was noted that the the device''s tip had melted.The case was aborted, and the patient has been scheduled later to attempt a retrograde popliteal approach.There was no reported patient harm.This report captures the turbo elite device which was damaged during the procedure, causing unintended radiation exposure, potential for harm.
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Manufacturer Narrative
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Patient''s date of birth unk.The device was returned to the manufacturer on 15 mar 2022.Device evaluation: the device was returned and evaluated by a cross functional team.The outer jacket of the device was melted, twisted, and wrinkled just distal to the bifurcate strain relief on the working length.Broken fibers and a breach to the device''s outer jacket were observed in this area.The outer jacket of the device became twisted, indicative that excessive force was applied to the device.The twists and wrinkles caused broken fibers; the broken fibers created laser energy and ultimately melted the outer jacket, resulting in the breach.This has been determined to be a use related failure.
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