BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? BURR

    MDR report key: 4210768 · Received October 29, 2014

    Report

    Report Number
    2134265-2014-06587
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: INVESTIGATION COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT AND AN ATTEMPT WAS MADE TO RETRIEVE THE HANDSHAKE CONNECTION FROM UNDER THE CATHETER BODY. IT WAS NOT POSSIBLE TO RETRIEVE THE HANDSHAKE CONNECTION. THE HOUSING OF THE CATHETER WAS DISMANTLED IN ORDER TO RETRIEVE THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTOR WAS CONTAINED WITHIN THE SHEATH OF THE CATHETER. THE SHEATH WAS CUT AND THE HANDSHAKE CONNECTOR WAS EXPOSED. THE COIL WAS OBSERVED TO BE KINKED PROXIMAL TO THE HANDSHAKE CONNECTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE OF THE LEFT ANTERIOR DESCENDING ARTERY. TWO 2.00MM ROTALINK BURR WERE USED FOR TREATMENT. DURING PLATFORMING OF THE FIRST BURR, IT WAS OBSERVED THAT THE HANDSHAKE CONNECTION WAS TANGLED AND BECAME DISCONNECTED. THE SECOND BURR WAS THEN SELECTED AND PLATFORMING WAS DONE AT THE DESIRED SPEED OF 160,000 RPM. HOWEVER, IT WAS NOTED THAT THE SPEED WAS SLOW AND WAS FLUCTUATING. THE PHYSICIAN THEN REPLACED THE DEVICE WITH ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE OF THE LEFT ANTERIOR DESCENDING ARTERY. TWO 2.00MM ROTALINK¿ BURR WERE USED FOR TREATMENT. DURING PLATFORMING OF THE FIRST BURR, IT WAS OBSERVED THAT THE HANDSHAKE CONNECTION WAS TANGLED AND BECAME DISCONNECTED. THE SECOND BURR WAS THEN SELECTED AND PLATFORMING WAS DONE AT THE DESIRED SPEED OF 160,000 RPM. HOWEVER, IT WAS NOTED THAT THE SPEED WAS SLOW AND WAS FLUCTUATING. THE PHYSICIAN THEN REPLACED THE DEVICE WITH ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693772 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680050 0017145006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ROTABLATOR BURR 2.00MM - CATHETER| ROTABLATOR BURR 1.75MM - CATHETER| ROTABLATOR ADVANCER| ROTABLATOR BURR 1.50MM - CATHETER| ROTABLATOR BURR 1.25MM -CATHETER