BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS 16F CAVACLEAR LASER SHEATH

    MDR report key: 15945846 · Received December 8, 2022

    Report

    Report Number
    1721279-2022-00225
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 8, 2022
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S DATE OF BIRTH, AGE: UNK. PATIENT'S WEIGHT: UNK. PATIENT'S ETHNICITY/RACE: UNK. RELEVANT TESTS/LABORATORY DATA: UNK. OTHER RELEVANT HISTORY: UNK. 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: (B)(4). THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. BASED ON THE COMPLAINT DETAILS, IT IS LIKELY THAT THE USER'S TECHNIQUE BY TWISTING BACK AND FORTH CAUSED THE BREAK IN THE WORKING LENGTH. PER THE IFU, IT STATES TO USE GENTLE PRESSURE ON THE LASER SHEATH TO ADVANCE THE DEVICE. 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 FILTER (IVCF) DUE TO CAVAL OCCLUSION, LEG SWELLING, AND PAIN. THE PHYSICIAN CHOSE A SPECTRANETICS 16F CAVACLEAR LASER SHEATH TO REMOVE THE FILTER. WHEN THE PHYSICIAN WAS USING THE CAVACLEAR, HE TORQUED THE DEVICE (TWISTED THE DEVICE BACK AND FORTH) IN ATTEMPT TO REMOVE THE IVCF. AFTERWARD, HE NOTICED THE CAVACLEAR'S BIFURCATE HANDLE FELT WARMER THAN NORMAL. EXAMINATION OF THE DEVICE REVEALED A PARTIAL SEPARATION ON THE WORKING LENGTH, JUST DISTAL TO THE BIFURCATE HANDLE WITH RED LIGHT EMITTING FROM THE AREA; THEREFORE, THE CAVACLEAR WAS REMOVED FROM THE PATIENT. A NEW 16F CAVACLEAR WAS USED TO SUCCESSFULLY REMOVE THE IVCF, AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451243 SPECTRANETICS 16F CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ THE SPECTRANETICS CORPORATION 500-516 F7P22J21A 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 Male CORDIS IVC PERMANENT FILTER MODEL UNK| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM