BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 18248101 · Received December 1, 2023

    Report

    Report Number
    3007284006-2023-00075
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 6, 2023
    Report Date
    December 1, 2023
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4): PATIENT'S WEIGHT UNK. D4): DEVICE SERIAL NUMBER UNK. G4): 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210024. H3): THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. H6): BASED ON THE COMPLAINT DETAILS AND PHILIPS PHYSICIAN ASSESSMENT, THE DEVICE BUCKLED WHEN FORWARD PRESSURE WAS APPLIED, INDICATING THAT EXCESSIVE FORCE WAS LIKELY APPLIED DURING USE. THE SPECTRANETICS IFU STATES TO USE GENTLE PRESSURE ON THE LASER SHEATH TO ADVANCE THE DEVICE. 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

    A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER DUE TO THE FILTER NO LONGER INDICATED. A PHILIPS 14F CAVACLEAR LASER SHEATH WAS USED, WITH AN 18F OUTER SHEATH, DOWN THE EXTERNAL JUGULAR (EJ) TO ATTEMPT FILTER REMOVAL. DURING THE PROCEDURE, THE OUTER JACKET BUCKLED UPON FORWARD PRESSURE NEAR THE BIFURCATE HANDLE, RESULTING IN A BREACH OF THE OUTER JACKET. THE PHYSICIAN FELT HEAT FROM THE BUCKLED AREA ON HIS GLOVED HAND, BUT THERE WAS NO INJURY DETECTED. USE OF THE CAVACLEAR WAS IMMEDIATELY DISCONTINUED, AND THE PROCEDURE WAS COMPLETED WITH USE OF ENDOBRONCHIAL 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
    1606121 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-514 F6P22L22A 00813132022969

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male 18F/40CM OUTERSHEATH MANUFACTURER UNK.| IVCF MANUFACTURER/MODEL UNK.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.