BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 18804018 · Received February 28, 2024

    Report

    Report Number
    3007284006-2024-00044
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 28, 2024
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    QRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2): PATIENT''S DATE OF BIRTH UNK A4): PATIENT''S WEIGHT UNK B6): RELEVANT TESTS/LABORATORY DATA UNK B7): OTHER RELEVANT HISTORY UNK G4): 510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: (B)(4). H3/H6): THE DEVICE WAS NOT RETURNED, THUS NO INVESTIGATION COULD BE COMPLETED, AND THE REPORTED FAILURE COULD NOT BE CONFIRMED. 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

    D4): DEVICE SERIAL NUMBER POPULATED. D9): THE DEVICE WAS RETURNED FOR EVALUATION ON 11MAR2024. G3): THE DEVICE EVALUATION AND INVESTIGATION WERE COMPLETED 13MAR2024. H3): THE CAVACLEAR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND A KINK, JUST DISTAL TO THE BIFURCATE HANDLE. AT THE AREA OF THE KINK, THE OUTER JACKET WAS BREACHED, AND EXPOSED AND BROKEN FIBERS WERE PRESENT. A SLIGHT KINK WAS LOCATED 21 CM FROM THE DISTAL TIP, WITH NO BREACH IN THE OUTER JACKET. A TWISTED OUTER JACKET WAS NOTED 5 CM FROM THE DISTAL TIP. NO ADDITIONAL DAMAGE WAS OBSERVED. H6): BASED ON THE DEVICE EVALUATION AND INVESTIGATION, THIS HAS BEEN DETERMINED TO BE A USE RELATED FAILURE. HISTORICALLY, THE DEVICE DAMAGE HAS BEEN OBSERVED WHEN EXCESSIVE FORCES ARE APPLIED TO THE SIDE OF THE OUTER JACKET. 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

    A PROCEDURE COMMENCED TO REMOVE AN INFERIOR VENA CAVA (IVC) FILTER DUE TO OCCLUSION. THE FILTER WAS NOTED TO BE DEEPLY EMBEDDED WITHIN THE VASCULATURE, IMPLANTED FOR 156 MONTHS. A PHILIPS 16F CAVACLEAR LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, EXPOSED FIBERS WERE OBSERVED AT THE PROXIMAL END OF THE CATHETER, DISTAL TO THE BIFURCATE HANDLE USE OF THE CAVACLEAR WAS DISCONTINUED, AND A NEW 16F CAVACLEAR WAS USED TO ATTEMPT FILTER REMOVAL WITH A SECOND DEVICE. HOWEVER, THE ATTEMPTS RESULTED IN A SIMILAR DEVICE FAILURE (MDR #3007284006-2024-00045). THE PROCEDURE WAS ABORTED AND THE IVC FILTER WAS LEFT IN PLACE, WITH NO IMMEDIATE PLANS FOR REMOVAL BY ALTERNATE MEANS. THE PATIENT WAS AWAKE THROUGHOUT THE PROCEDURE, WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE FIRST CAVACLEAR IN USE, RESULTING IN UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932449 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 F7P23L30A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male ARGON MEDICAL OPTION ELITE IVC FILTER.| SECOND PHILIPS 16F CAVACLEAR LASER SHEATH.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.