BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 19811715 · Received July 23, 2024

    Report

    Report Number
    3007284006-2024-00146
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 23, 2024
    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

    G4): 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3): THE CAVACLEAR DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A KINK IN THE OUTER JACKET, JUST PROXIMAL TO THE BIFURCATE HANDLE. IN THE AREA OF THE KINK, THE OUTER JACKET WAS MELTED AND BREACHED, WITH BROKEN AND EXPOSED FIBERS OBSERVED. 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 NEAR THE BIFURCATE WHEN EXCESSIVE FORCES ARE APPLIED TO THE SIDE OF THE OUTER JACKET AT OR NEAR THE BIFURCATE. THE DEVICE BECOMES KINKED, AND THEN BROKEN FIBERS AT THE AREA OF THE KINK PRODUCE HEAT, WHICH CREATES A BREACH IN THE OUTER JACKET. 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 GREENFIELD PERMANENT ICVF, DUE TO SYMPTOMS OF BACK PAIN AND REQUEST FOR REMOVAL. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. AFTER USING THE CAVACLEAR FOR TWO CYCLES, IT WAS NOTED THAT THE BIFURCATE HANDLE WAS GENERATING HEAT, AND UPON REMOVAL, EXPOSED FIBERS WERE OBSERVED NEAR THE HANDLE. A NEW 16F CAVACLEAR WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORT PATIENT OR USER HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472469 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 F7P24A19A 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female BOSTON SCIENTIFIC GREENFIELD IVCF FILTER| COOK MEDICAL 18F PURPLE INTRODUCER SHEATH| PHILIPS LASER SYSTEM| TERUMO GLIDEWIRE STIFF 0.035 GUIDE WIRE