BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3233481 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-05080
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE GUIDEWIRE WAS RETURNED INSERTED IN THE CATHETER UNIT. IT WAS NOTED THAT THE BURR OF THE CATHETER UNIT WAS DETACHED FROM THE CATHETER AND WAS NOT RETURNED WITH THE DEVICE. THE COIL WAS MICROSCOPICALLY EXAMINED. IT WAS NOTED THAT THE DISTAL WAS STRETCHED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BURR SEPARATION OCCURRED. THE 99% TARGET LESIONS WERE LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND PROXIMAL LEFT CIRCUMFLEX ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY DEVICE WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESIONS. INCREASED PRESSURE WAS NOT APPLIED UPON ABLATION. TOTAL ABLATION DURATION WAS ONE MINUTE. AFTER ABLATING BOTH LESIONS, THE DEVICE WAS REMOVED USING DYNAGLIDE MODE. NO RESISTANCE WAS NOTED UPON REMOVAL. UPON REMOVAL OF THE BURR FROM THE Y-CONNECTOR USING DYNAGLIDE MODE, IT WAS THEN NOTED THAT THE BURR WAS SEPARATED INSIDE THE GUIDE CATHETER. THE SEPARATED BURR WAS THEN RETRIEVED TOGETHER WITH THE REMOVAL OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BURR SEPARATION OCCURRED. THE 99% TARGET LESIONS WERE LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND PROXIMAL LEFT CIRCUMFLEX ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY DEVICE WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESIONS. INCREASED PRESSURE WAS NOT APPLIED UPON ABLATION. TOTAL ABLATION DURATION WAS ONE MINUTE. AFTER ABLATING BOTH LESIONS, THE DEVICE WAS REMOVED USING DYNAGLIDE MODE. NO RESISTANCE WAS NOTED UPON REMOVAL. UPON REMOVAL OF THE BURR FROM THE Y-CONNECTOR USING DYNAGLIDE MODE, IT WAS THEN NOTED THAT THE BURR WAS SEPARATED INSIDE THE GUIDE CATHETER. THE SEPARATED BURR WAS THEN RETRIEVED TOGETHER WITH THE REMOVAL OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334214 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 15756582

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: ROTAWIRE FLOPPY/0.009/BSJ| GUIDING CATHETER: MACH1/8FR/BSJ| INFLATION DEVICE: E-CHAGE/SJM| STENT: XIENCEPRIME/2.5×23/AVJ