BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 23415797 · Received October 29, 2025

    Report

    Report Number
    3007284006-2025-00227
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 29, 2025
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT DATE OF BIRTH AND AGE - NOT AVAILABLE FROM FACILITY. A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. A4) PATIENT WEIGHT - NOT AVAILABLE FROM FACILITY. A6) PATIENT RACE - NOT AVAILABLE FROM FACILITY. B6/B7) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - NOT AVAILABLE FROM FACILITY. D4) DEVICE SERIAL NUMBER - NOT AVAILABLE FROM FACILITY. G4) 510K/PMS NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3/H6) THE CAVACLEAR WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. 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 FILTER (IVCF) REMOVAL PROCEDURE COMMENCED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO REMOVE AN OPTIONAL IVCF DUE TO PATIENT NO LONGER NEEDING IT. DURING USE, THE CAVACLEAR OUTER JACKET SEPARATED NEAR THE HANDLE. ALLIGATOR FORCEPS WERE USED TO COMPLETE THE PROCEDURE, 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
    219377 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 0303476295 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OPTIONAL IVCF (MANUFACTURER, MODEL UNK)| PHILIPS LASER SYSTEM