BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2142695 · Received June 9, 2011

    Report

    Report Number
    3004742232-2011-00017
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS DISCARDED; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE AND THE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE TIP OF THE VIPERWIRE WAS SHEARED OFF AND REMAINS IN THE PT'S BODY. THE LESION BEING TREATED WAS SEVERELY CALCIFIED, 70% STENOTIC. IT MEASURED APPROXIMATELY 13CM IN LENGTH AND WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE PHYSICIAN USED A 6F INTRODUCER SHEATH TO CROSS THE TARGET LESION. USING THE DIAMONDBACK 1.5 CLASSIC CROWN OAD, THE PHYSICIAN PERFORMED TWO RUNS AT LOW SPEED (80K RPMS) LASTING 25SECS EACH. AFTER 15SECS DURING THE THIRD RUN AT 80K RPMS, THE DIAMONDBACK OAD CROWN WAS PUSHED OVER THE TIP OF THE VIPERWIRE CAUSING THE TIP OF THE WIRE TO BE SHAVED OFF IN THE PT'S AT VESSEL. IT WAS NOTED THAT HALF-WAY THROUGH THIS RUN THE FLUORO TURNED OFF PREVENTING VISIBILITY IN THE TREATMENT REGION. THE CAUSE OF THE LOSS OF FLUORO IS UNK. THE DEVICE MADE A HIGH-PITCHED NOISE AND THE INTERVENTION WAS IMMEDIATELY HALTED. THE VASCULAR SURGEON WAS CONSULTED AND IT WAS DETERMINED THAT IT WAS NOT NECESSARY TO REMOVE THE TIP OF THE WIRE AS THE PT'S LESIONS WERE IMPROVED AND SHE HAD A PALPABLE PULSE IN THE AT WHICH WAS NON-EXISTENT PRIOR TO TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED VPR-GW-14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other