BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 23191077 · Received October 1, 2025

    Report

    Report Number
    3007284006-2025-00196
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 17, 2025
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    QRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4) DEVICE SERIAL NUMBER POPULATED. D9) THE CAVACLEAR DEVICE WAS RETURNED TO THE MANUFACTURER 15OCT2025. H3) VISUAL INSPECTION FOUND A KINK ALONG THE WORKING LENGTH, JUST DISTAL TO THE BIFURCATE HANDLE. THERE WAS A CONFIRMED BREACH IN THE OUTER JACKET, WITH BROKEN AND CHARRED FIBERS, AND THE BRAID WAS EXPOSED. SLIGHT BIOLOGICS WERE PRESENT ON THE OUTER JACKET, AND WRINKLES 12 MM FROM THE DISTAL TIP. H6) BASED ON THE DEVICE EVALUATION AND INVESTIGATION, THIS HAS BEEN DETERMINED TO BE A USE RELATED FAILURE. HISTORICALLY, THE MANUFACTURER HAS SEEN THIS FAILURE WHEN THE FORCE REQUIRED TO ADVANCE AND MANEUVER IS GREATER THAN THE FORCE THAT THE WORKING LENGTH CAN ACCOMMODATE. WHEN THESE FORCES ARE APPLIED TO THE SIDE OF THE OUTER JACKET, AT OR NEAR THE BIFURCATE HANDLE, THE DEVICE BECOMES KINKED. BROKEN FIBERS IN THE AREA REDIRECT THE LASER ENERGY, WHICH CREATES A BREACH IN THE OUTER JACKET. TYPE OF INVESTIGATION CODE B01 REPLACED (FROM B17). INVESTIGATION FINDINGS CODE C0706 REPLACED (FROM C20). INVESTIGATION CONCLUSIONS CODE D1102 REPLACED (FROM D14). ALL OTHER CODES REMAIN APPLICABLE AS LISTED IN THE INITIAL MDR. 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.

    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. 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 FOR EVALUATION, THUS NO RETURNED 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 TO REMOVE A BOSTON SCIENTIFIC GREENFIELD PERMANENT IVCF DUE TO THE PATIENT NO LONGER NEEDING IT. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, THE OUTER JACKET BECAME DETACHED, WITH VISIBLE FIBERS EXPOSED. A NEW CAVACLEAR WAS 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
    2106779 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 F7P24B22A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male BOSTON SCIENTIFIC GREENFIELD IVCF.| COOK MEDICAL 18F INTRODUCER SHEATH.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.| TERUMO 0.035 GLIDEWIRE GUIDE WIRE.