BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 23569124 · Received November 17, 2025

    Report

    Report Number
    3007284006-2025-00240
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 17, 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

    A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. D4) DEVICE SERIAL NUMBER UNKNOWN. G4) 510K/PMS NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3/H6) THE CAVACLEAR WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED AND 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

    AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE COMMENCED TO REMOVE A CORDIS OPTEASE OPTIONAL IVCF DUE TO NO LONGER INDICATED. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, WHEN THE CAVACLEAR WAS BEING ROCKED BACK AND FORTH TO THE FILTER, IT WAS NOTICED THAT THE DISTAL TIP FRAYED, EXPOSING THE FIBERS (MDR #3007284006-2025-00239). A SECOND 16F CAVACLEAR WAS UTILIZED; HOWEVER, THE SAME MALFUNCTION OCCURRED (MDR #3007284006-2025-00240). THEN, A THIRD 16F CAVACLEAR WAS USED, AND EXPERIENCED THE SAME ISSUE (MDR #3007284006-2025-00241). THE PROCEDURE WAS COMPLETED MANUALLY WITH FORCEPS, 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
    280143 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 0303448426 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male ANGIODYNAMICS SOS OMNI GUIDE CATHETER (SIZE UNK)| GORE MEDICAL 18X33 DRYSEAL INTRODUCER SHEATH| HORIZON MEDICAL 0.35 BENSON GUIDEWIRE| PHILIPS LASER SYSTEM