BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS 14F CAVACLEAR LASER SHEATH

    MDR report key: 15583738 · Received October 11, 2022

    Report

    Report Number
    1721279-2022-00175
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 11, 2022
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. BASED ON THE COMPLAINT DETAILS, EXCESSIVE FORCE WAS APPLIED DURING USE. 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 PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER. THE FILTER WAS NO LONGER NEEDED, AND REMOVING IT WOULD ELIMINATE THE NEED FOR ANTICOAGULATION. THE PHYSICIAN CHOSE A SPECTRANETICS 14F CAVACLEAR LASER SHEATH TO REMOVE THE FILTER. AS THE CAVACLEAR WAS BEING USED, EXCESSIVE PUSH/PULL FORCE WAS APPLIED BY THE PHYSICIAN. AS A RESULT, THE AREA WHERE THE DEVICE''S BIFURCATE HANDLE AND THE WORKING LENGTH MEET, BENT AT A 90 DEGREE ANGLE, EXPOSING THE FIBERS. THE PHYSICIAN DISCONTINUED USE OF THE FIRST CAVACLEAR, OBTAINED A NEW CAVACLEAR, AND THE FILTER WAS SUCCESSFULLY REMOVED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943091 SPECTRANETICS 14F CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ THE SPECTRANETICS CORPORATION 500-514 C6P21J23A 00813132022969

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female COOK MEDICAL GUNTHER TULIP VENA CAVA FILTER| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM