BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3822525 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02742
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE CATHETER AND THE ADVANCER WERE NOT CONNECTED UPON RETURN. THE HOUSING OF THE CATHETER WAS DISMANTLED AND DETACHED FROM THE DEVICE AND A ROTAWIRE WAS RUNNING THROUGH THE ENTIRE LENGTH OF THE CATHETER. THERE WAS BLOOD IN THE SHAFT OF THE CATHETER. THE GUIDE WIRE RUNNING THROUGH THE CATHETER COULD NOT BE REMOVED DUE TO THE PRESENCE OF DRIED BLOOD IN THE CATHETER. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT. THE HANDSHAKE CONNECTOR OF THE ADVANCER WAS FREE FROM DAMAGE. THE HANDSHAKE CONNECTOR OF THE CATHETER COULD NOT BE INSPECTED AS THE BURR COULD NOT BE PUSHED BACK TO EXPOSE THE HANDSHAKE CONNECTOR DUE TO THE RESISTANCE ENCOUNTERED AS A RESULT OF THE PRESENCE OF THE DRIED BLOOD. A TUG TEST WAS ATTEMPTED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED. THE COMPLAINT ADVANCER UNIT WAS CONNECTED TO A TEST CATHETER TO BE WET TESTED AND THE ROTABLATOR SYSTEM WAS UNABLE TO REACH OPTIMUM SPEED AND THE DEVICE STALLED. THE COMPLAINT ADVANCER WAS DISMANTLED AND THE ULTEM WAS FOUND TO BE MELTED. THERE WAS SLIGHT CORROSION ON THE TURBINE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE DFU STATES: NEVER OPERATE THE ROTABLATOR ADVANCER WITHOUT SALINE INFUSION. FLOWING SALINE IS ESSENTIAL FOR COOLING AND LUBRICATING THE WORKING PARTS OF THE ADVANCER. OPERATION OF THE ADVANCER WITHOUT PROPER SALINE INFUSION MAY RESULT IN PERMANENT DAMAGE TO THE ADVANCER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURR WAS STUCK IN LESION. THE STENOSED TARGET LESION WAS LOCATED AT THE CIRCUMFLEX ARTERY. A 1.50MM ROTALINK PLUS WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE, IT WAS NOTED THAT THE BURR GOT STUCK IN THE LESION. THE BURR WAS MANUALLY REMOVED FROM THE VESSEL SUCCESSFULLY. PROCEDURE WAS COMPLETED WITH A BALLOON AND A STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURR WAS STUCK IN LESION. THE STENOSED TARGET LESION WAS LOCATED AT THE CIRCUMFLEX ARTERY. A 1.50MM ROTALINK¿ PLUS WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE, IT WAS NOTED THAT THE BURR GOT STUCK IN THE LESION. THE BURR WAS MANUALLY REMOVED FROM THE VESSEL SUCCESSFULLY. PROCEDURE WAS COMPLETED WITH A BALLOON AND A STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303774 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 16358500

    Patients

    Seq Age Sex Outcome Treatment
    1