BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3242462 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-05083
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 25, 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 TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE COMPLAINT BURR UNIT WAS CARRIED OUT. A TUG TEST AND A CONNECT/DISCONNECT TEST WAS PERFORMED AND NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTION. THE ROTABLATOR BURR WAS WIRE GUIDED USING A TEST GUIDE WIRE AND NO ISSUES WERE NOTED. THE BURR WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. THE ROTABLATOR UNIT WAS WET TESTED AND THE OPTIMUM SPEED WAS REACHED WITHOUT ANY ISSUE. 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 PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A PERCUTANEOUS CORONARY INTERVENTION, UNSTABLE ROTATIONAL SPEED WAS OBSERVED. THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED . A 1.25MM ROTABLATOR ROTALINK PLUS WAS USED TO TREAT THE LESION. DURING PREPARATION, WHILE TESTING THE ROTATION SPEED OF THE DEVICE BEFORE INSERTING A GUIDING CATHETER, UNSTABLE ROTATIONAL SPEED WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A PERCUTANEOUS CORONARY INTERVENTION, UNSTABLE ROTATIONAL SPEED WAS OBSERVED. THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED . A 1.25 MM ROTABLATOR ROTALINK PLUS WAS USED TO TREAT THE LESION. DURING PREPARATION, WHILE TESTING THE ROTATION SPEED OF THE DEVICE BEFORE INSERTING A GUIDING CATHETER, UNSTABLE ROTATIONAL SPEED WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342809 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0016021963

    Patients

    Seq Age Sex Outcome Treatment
    1