BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3103200 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03231
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED A GUIDEWIRE WAS RETURNED INSERTED IN THE PLUS UNIT. THE GUIDEWIRE COULD NOT BE REMOVED FROM THE CATHETER UNIT. BLOOD WAS NOTED THROUGHOUT THE CATHETER SHEATH. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION AND NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. THE ROTABLATOR PLUS WAS DISCONNECTED AND A LARGE AMOUNT OF BLOOD WAS NOTED AT THE CONNECTION POINT. THE ADVANCER UNIT WAS DISMANTLED AND A MELTED ULTEM WAS EVIDENT. BLOOD WAS NOTED ON THE ADVANCER TURBINE, INDICATING INSUFFICIENT SALINE WAS USED DURING THE PROCEDURE. THE BURR WAS MICROSCOPICALLY EXAMINED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ANNULUS OF THE BURR WAS NOT WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A MELTED ULTEM IS DUE TO THE INTERRUPTION OF SALINE OR BY INSUFFICIENT FLOW OF SALINE. THE DIRECTIONS FOR USE 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." THEREFORE, THE ROOT CAUSE IS USER ERROR RELATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03232. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END TO MID LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT A POPPING SOUND WAS HEARD FROM THE ROTA CONSOLE THEN ROTATION SPEED WAS UNABLE TO INCREASE. THE PHYSICIAN THEN REMOVED THE 1.5M ROTABLATOR ROTALINK BURR. IT WAS NOTED THAT THE 1.5MM ROTALINK BURR TESTED FINE OUTSIDE THE PATIENT. HOWEVER, REGURGITATION OCCURRED IN INTRAVENOUS LINE OF THE BURR, AND IT WAS OBSERVED THAT THE BURR WAS LODGED AT APPROXIMATELY 5CM SHORT OF THE GUIDING CATHETER. THE BURR WAS SUCCESSFULLY REMOVED TOGETHER WITH THE ROTA WIRE AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03232. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END TO MID LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT A POPPING SOUND WAS HEARD FROM THE ROTA CONSOLE THEN ROTATION SPEED WAS UNABLE TO INCREASE. THE PHYSICIAN THEN REMOVED THE 1.5M ROTABLATOR ROTALINK BURR. IT WAS NOTED THAT THE 1.5MM ROTALINK BURR TESTED FINE OUTSIDE THE PATIENT. HOWEVER, REGURGITATION OCCURRED IN INTRAVENOUS LINE OF THE BURR, AND IT WAS OBSERVED THAT THE BURR WAS LODGED AT APPROXIMATELY 5CM SHORT OF THE GUIDING CATHETER. THE BURR WAS SUCCESSFULLY REMOVED TOGETHER WITH THE ROTA WIRE AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203450 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0015815257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention