BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVACLEAR LASER SHEATH

    MDR report key: 18804022 · Received February 28, 2024

    Report

    Report Number
    3007284006-2024-00045
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 9, 2024
    Report Date
    April 4, 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

    B5): THIS EVENT IS NO LONGER REPORTABLE AFTER DEVICE EVALUATION AND INVESTIGATION COMPLETED. D4): DEVICE SERIAL NUMBER POPULATED D9): THE DEVICE WAS RETURNED TO THE MANUFACTURER 12MAR2024. G3): THE DEVICE EVALUATION AND INVESTIGATION WERE COMPLETED 13MAR2024. H3): THE CAVACLEAR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO BREACHES TO THE OUTER JACKET. HOWEVER, THE OUTER JACKET WAS TWISTED 45 CM FROM THE DISTAL TIP, BUNCHED AND WRINKLED 47 CM FROM DISTAL TIP, AND BUNCHED JUST DISTAL TO THE BIFURCATE HANDLE. DURING FUNCTIONAL TESTING, DEAD FIBERS WERE DETECTED IN THE AREAS OF THE OUTER JACKET DEFORMITIES. H6): BASED ON THE DEFORMATION OF THE OUTER JACKET AND DEAD FIBERS, THE CAUSE OF THE DAMAGE HAS BEEN DETERMINED TO BE USE RELATED. MEDICAL DEVICE PROBLEM CODE CORRECTED TO 2976 (FROM 1562). HECC CODE CORRECTED TO 4582 (FROM 4565). TYPE OF INVESTIGATION CODE 10 REPLACED (FROM 4114). INVESTIGATION FINDINGS CODE 3243 REPLACED (FROM 3221). INVESTIGATION CONCLUSIONS CODE 61 REPLACED (FROM 67). ALL OTHER CODES 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.

    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 (MDR #3007284006-2024-00044). 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 SECOND CAVACLEAR IN USE, RESULTING IN UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

    Description of Event or Problem · 0

    THIS EVENT IS NO LONGER REPORTABLE FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM. PER THE RETURNED DEVICE EVALUATION, NO BREACH TO THE OUTER JACKET WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932453 CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ PHILIPS IMAGE GUIDED THERAPY CORPORATION 500-516 F7P24A19A

    Patients

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