BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2901290 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08224
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE SHEATH WAS TORN/SPLIT APPROXIMATELY 24CM FROM THE STRAIN RELIEF AND WAS OCCLUDED WITH BLOOD. NO ADDITIONAL VISUAL ISSUES WERE NOTED. A TUG TEST WAS PERFORMED AND NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. THE BURR WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THE ANNULUS OF THE BURR. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DAMAGE TO THE CATHETER SHEATH IS ASSOCIATED WITH OVER-TIGHTENING OF THE HEMOSTASIS VALVE. OVER TIGHTENING OF THE HEMOSTASIS VALVE CAN RESULT IN THE CATHETER SHEATH BECOMING CRUSHED. THIS WOULD RESULT IN THE SHEATH TO SPLIT AND WOULD CAUSE THE SHEATH TO LEAK. THEREFORE ROOT CAUSE IS USER RELATED. THE ROTABLATOR DIRECTIONS FOR USE STATES: "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

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, SHEATH DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). DURING THE COMPLETION OF ABLATION USING A 1.5MM ROTALINK PLUS BURR, A HOLE WAS NOTICED IN THE TEFLON SHEATH. THE PROCEDURE WAS COMPLETED WITH NO FURTHER DEVICES NEEDED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, SHEATH DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). DURING THE COMPLETION OF ABLATION USING A 1.5MM ROTALINK PLUS BURR, A HOLE WAS NOTICED IN THE TEFLON SHEATH. THE PROCEDURE WAS COMPLETED WITH NO FURTHER DEVICES NEEDED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9850 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15536661

    Patients

    Seq Age Sex Outcome Treatment
    1