BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2100811 · Received May 19, 2011

    Report

    Report Number
    3004742232-2011-00012
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, AN EMBOLIZATION EVENT OCCURRED. THE LESION BEING TREATED WAS A HEAVILY CALCIFIED, 60MM SFA LESION. THE PHYSICIAN USED A 2.0 DIAMONDBACK OAD AND PERFORMED THREE RUNS; ONE RUN AT LOW SPEED FOR 30 SECONDS, THEN MEDIUM SPEED FOR 30 SECONDS, AND THEN HIGH SPEED FOR 30 SECONDS. HE ADMINISTERED 400 MCG IV NITROGLYCERINE PRE-TREATMENT AND 200MCG BETWEEN EACH RUN. FOLLOWING THE INTERVENTION, THE AT AND PERONEAL VESSELS DEMONSTRATED SLUGGISH FLOW, SO HE USED A FETCH ASPIRATION CATHETER TO ASPIRATE BOTH VESSELS AND FOLLOWED UP WITH THE BALLOON ANGIOPLASTY USING A 5X60 BALLOON INFLATED TO 6ATMS. THREE WRITTEN REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO REGARDING THIS EVENT, BUT NO INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. PRD-SC30-200 45160

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention