BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1970605 · Received January 25, 2011

    Report

    Report Number
    2134265-2011-00023
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    September 29, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE CATHETER UNIT WAS RETURNED WITH BLOOD THROUGHOUT THE ENTIRE CATHETER SHEATH. THE SHEATH WAS TORN APPROXIMATELY 26CM FROM THE STRAIN RELIEF. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER/USE ERROR. THE DAMAGE TO THE CATHETER SHEATH IS ASSOCIATED WITH OVER-TIGHTENING OF THE HEMEOSTASIS VALVE. THE ROTABLATOR DIRECTIONS FOR USE (DFU) STATES THAT "IF THE HEMOSTASIS VALVE IS TIGHTENED EXCESSIVELY, IT CAN CRUSH THE SHEATH AROUND THE DRIVE SHAFT AND CAUSE PERMANENT DAMAGE TO THE ROTALINK CATHETER. THE HEMOSTASIS VALVE SHOULD BE CLOSED JUST TIGHT ENOUGH TO PREVENT BLOOD LOSS, BUT STILL ALLOW THE ROTALINK SHEATH TO SLIDE THROUGH THE VALVE". (B)(4).

    Description of Event or Problem · 1

    COMPLAINT IS REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE PATIENT EXPERIENCED NO FLOW. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 1.5MM ROTALINK BURR WAS USED FOR ABLATION AT APPROXIMATELY 160,000 RPMS. THE 1.5MM ROTALINK BURR MADE AN ABNORMAL NOISE AND THE CONSOLE SHOWED A STALL ERROR. ALL CONNECTIONS WERE CHECKED, AND THE BURR THEN WORKED FOR ABOUT 20 SECONDS BEFORE STALLING AGAIN. THE SYSTEM WOULD NOT SWITCH INTO DYNAGLIDE, SO THE ROTALINK BURR WAS REMOVED WITH THE ROTAWIRE GUIDE WIRE BY PULLING IT BACK MANUALLY INTO THE UNSPECIFIED GUIDE CATHETER. THE PATIENT EXPERIENCED NO FLOW WHICH WAS TREATED WITH NITRO AND VERAPRAMIL. THERE WERE NO EKG OR BLOOD PRESSURE CHANGES. UPON REMOVAL OF THE BURR, DAMAGE WAS NOTED TO THE PROXIMAL SHEATH. AN UNSPECIFIED 0.014 GUIDE WIRE WAS ADVANCED AND THE PROCEDURE WAS COMPLETED WITH POBA AND STENTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 13670099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROTALINK ADVANCER| ROTAWIRE GUIDE WIRE