BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 21417198 · Received February 19, 2025

    Report

    Report Number
    3007284006-2025-00034
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 19, 2025
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT'S DATE OF BIRTH- NOT AVAILABLE FROM FACILITY. A3B) PATIENT'S GENDER- NOT AVAILABLE FROM FACILITY. B6) RELEVANT TESTS/LABORATORY DATA- NOT AVAILABLE FROM FACILITY. D4) DEVICE SERIAL NUMBER- NOT AVAILABLE FROM FACILITY. G4) 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210014. H3) THE DEVICE WAS DISCARDED; THUS NO INVESTIGATION COULD BE COMPLETED. H6) GREAT VESSEL PERFORATION IS A KNOWN RISK OF COMPLICATION WITH USE OF THE CAVACLEAR 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

    AN INFERIOR VENA CAVA (IVC) FILTER REMOVAL COMMENCED BECAUSE THE PATIENT NO LONGER NEEDED THE IVC FILTER. PRIOR TO USE OF THE SPECTRANETICS 16F CAVACLEAR LASER SHEATH, OTHER MODALITIES WERE USED TO ATTEMPT REMOVAL, BUT UNSUCCESSFUL DUE TO THE FILTER BEING EMBEDDED TO THE IVC. THEN, THE CAVACLEAR WAS ADVANCED AND DURING USE, AN IVC PERFORATION WAS DETECTED VIA ANGIOGRAM. THEREFORE, A STENT WAS PLACED TO TREAT THE PERFORATION, WHILE ALSO SECURING THE FILTER TO THE VESSEL WALL. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE CAVACLEAR IN USE WHEN THE IVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE CAVACLEAR DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039341 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 0303360660 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Life Threatening COOK MEDICAL TULIP OPTIONAL IVC FILTER| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM