BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2042561 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01299
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE CATHETER UNIT WAS ATTACHED TO A TEST ADVANCER UNIT AND AN ATTEMPT WAS MADE TO WET TEST THE CATHETER DEVICE. SALINE LEAKED APPROXIMATELY 22CM FROM THE STRAIN RELIEF OF THE CATHETER SHEATH. A PIN HOLE WAS NOTICED. IT WAS NOT POSSIBLE TO WET TEST THE CATHETER DEVICE DUE TO THE SALINE LEAK. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/ USE ERROR. THE DFU 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 HEMEOSTASIS 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 TREATMENT PROCEDURE, THE SHAFT OF THE BURR WAS PUNCTURED. THE 1.75MM ROTABLATOR BURR CATHETER WAS PREPPED AND PLATFORMED. ONCE THE BURR WAS INSIDE THE BODY, THE DEVICE WAS NOT ABLE TO MAINTAIN A ROTATIONAL SPEED. THE BURR WAS THEN REMOVED FROM THE BODY AND A KINK/PUNCTURE IN THE SHAFT OF THE BURR CATHETER WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680040 13941113

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTAWIRE GUIDE WIRE| ROTABLATOR ADVANCER