BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 19923980 · Received August 6, 2024

    Report

    Report Number
    3007284006-2024-00161
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 6, 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

    A4): PATIENT WEIGHT UNKNOWN. A5): PATIENT ETHNICITY UNKNOWN. A6): PATIENT RACE UNKNOWN. B6/B7): PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. D4): DEVICE SERIAL NUMBER UNKNOWN. G4): 510K/PMS NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3/H6): THE CAVACLEAR WAS NOT RETURNED, THUS NO RETURNED 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) REMOVAL PROCEDURE COMMENCED TO REMOVE A TRAPEASE PERMANENT IVCF DUE TO SYMPTOMATIC IVC OCCLUSIONS. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, A SPLIT IN THE OUTER JACKET WITH VISIBLE FIBERS WAS OBSERVED, JUST DISTAL TO THE BIFURCATE HANDLE. A NEW 16F 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
    1636101 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 67 YR Male .CORDIS TRAPEASE PERMANENT VENA CAVA FILTER| 0.035 GLIDE GUIDE WIRE, MANUFACTURER UNK.| COOK MEDICAL 18F INTRODUCER SHEATH.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.