BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 16F CAVACLEAR LASER SHEATH

    MDR report key: 15835621 · Received November 21, 2022

    Report

    Report Number
    1721279-2022-00203
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    October 28, 2022
    Report Date
    November 21, 2022
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    QRJ
    UDI-DI
    00813132022976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K/PMA NUMBER IS NOT APPLICABLE. DE NOVO NUMBER: DEN210014. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. VESSEL PERFORATION IS A KNOWN RISK OF COMPLICATION WITH USE OF THE CAVACLEAR 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

    AN INFERIOR VENA CAVA FILTER (IVCF) REMOVAL COMMENCED BECAUSE THE PATIENT NO LONGER NEEDED THE IVCF. IT WAS NOTED THAT STRUTS OF THE IVCF HAD PREVIOUSLY PERFORATED AND WERE LOCATED OUTSIDE THE IVC. ONCE THE FILTER HAD BEEN REMOVED USING A SPECTRANETICS CAVACLEAR LASER SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. A COVERED STENT WAS USED TO SEAL OFF AN IVC PERFORATION AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE CAVACLEAR IN USE WHEN THE IVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE CAVACLEAR DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558334 SPECTRANETICS 16F CAVACLEAR LASER SHEATH LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL QRJ THE SPECTRANETICS CORPORATION 500-516 FP22G15A 00813132022976

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| L CORDIS OPTEASE RETRIEVABLE IVC FILTER.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.