BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-POWER LASER ATHERECTOMY CATHETER

    MDR report key: 18867892 · Received March 8, 2024

    Report

    Report Number
    3007284006-2024-00055
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 15, 2024
    Report Date
    April 4, 2024
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MCW
    UDI-DI
    00813132026783
    PMA / PMN Number
    K180694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2): PATIENT''S DATE OF BIRTH, AGE UNK A4): PATIENT''S WEIGHT UNK D4): DEVICE SERIAL NUMBER UNK H3/H6): THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE EVALUATION HAS NOT YET BEGUN. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION AND INVESTIGATION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    B5): NEW INFORMATION STATED THAT THE DEVICE WAS BEING USED IN-STENT. G3): THE DEVICE EVALUATION AND INVESTIGATION WERE COMPLETED 25MAR2024. H3): THE TURBO-POWER WAS RETURNED INTACT TO AN 0.014 NON-PHILIPS GUIDE WIRE, ALONG WITH PORTIONS OF A COOK MEDICAL INTRODUCER SHEATH. VISUAL INSPECTION OF THE TURBO-POWER FOUND WRINKLES PRESENT ALONG THE WORKING LENGTH, AND A 3 CM BREACH OF THE OUTER JACKET WAS NOTED, 64 CM PROXIMAL TO THE DISTAL TIP. IN THE AREA OF THE BREACH, EXPOSED FIBERS WERE PRESENT, BUT NOT BROKEN, AND THE INNER LUMEN WAS VISIBLE. ADDITIONALLY, THE GUIDE WIRE WAS PROTRUDING FROM THE TURBO-POWER PROXIMAL END AND DISTAL TIP. COILS AND PORTIONS OF THE INNER LUMEN FROM THE COOK WERE WRAPPED AROUND THE OUTER JACKET OF THE TURBO-POWER, SPANNING 64 CM FROM THE DISTAL TIP. THE COOK SHAFT WAS DETACHED FROM THE VALVE, AND THE VALVE WAS STUCK ON THE TURBO-POWER, 64 CM FROM THE DISTAL TIP. BEYOND THE TURBO-POWER DISTAL TIP, PORTIONS OF THE COOK INNER LUMEN WERE FOUND STUCK WITHIN THE COILS. DURING FUNCTIONAL TESTING, THE OUTER JACKET WAS INCISED, WHICH CONFIRMED THE INNER LUMEN WAS INTACT, AND HEAVY BIOLOGICS WERE OBSERVED. H6): BASED ON ADDITIONAL INFORMATION AND DEVICE EVALUATION, CHALLENGES WITH THE ROTAREX DEVICE BEFORE USE OF THE TURBO-POWER, AND THE TURBO-POWER BEING USED IN-STENT, MAY HAVE CONTRIBUTED TO THE DAMAGE OBSERVED. HOWEVER, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE ESTABLISHED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO USE OF SPECTRANETICS DEVICES, MULTIPLE TOOLS (COOK MEDICAL 6F INTRODUCER SHEATH, BD ROTAREX EXCISIONAL ATHERECTOMY SYSTEM) WERE USED TO BEGIN THE PROCEDURE. PER REPORT, THE ROTAREX DISTAL TIP BROKE OFF INSIDE THE COOK SHEATH, AND A SNARE WAS USED TO REMOVE THE SEPARATED PORTION. THEN, A SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER WAS LOADED OVER A GUIDE WIRE AND INSERTED THROUGH THE SAME COOK SHEATH. AFTER TREATMENT AND DURING REMOVAL, THE TURBO-POWER WAS STUCK WITHIN THE SHEATH, NECESSITATING REMOVAL AS A UNIT. UPON OBSERVATION, EXPOSED FIBERS AND SEPARATION OF THE CATHETER WERE NOTED. IN ADDITION, THE COOK SHEATH''S COILS/BRAIDS WERE LOOSE AND UNRAVELED, BOUND AGAINST THE TURBO-POWER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING SUBMITTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159950 TURBO-POWER LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW SPECTRANETICS CORPORATION 420-050 FTS22E17A 00813132026783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male BD ROTAREX EXCISIONAL ATHERECTOMY SYSTEM| COOK MEDICAL 6F INTRODUCER SHEATH| GUIDE CATHETER MANUFACTURER/SIZE UNK| GUIDE WIRE MANUFACTURER/SIZE UNK| SNARE MANUFACTURER/TYPE UNK| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM