BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4173193 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06575
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 2014
    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). DEVICE EVALUATED BY MFR:THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 BURR REMOVAL DIFFICULTY FROM THE LESION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 1.25MM ROTALINK¿ PLUS WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE, ABLATION WAS PERFORMED THREE TIMES AND WHEN ADVANCED FOR 4TH ABLATION, IT FAILED TO CROSS THE LESION. AN ATTEMPT TO INCREASE THE ROTATION SPEED WAS DONE BUT IT FAILED TO GO UP MORE THAN 190,000RPM. ABLATION WAS TRIED BUT THE BURR STALLED ITS ROTATION SPEED. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY REMOVING OF THE DEVICE FROM THE LESION DUE TO SLIGHT RESISTANCE ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655504 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0016764530

    Patients

    Seq Age Sex Outcome Treatment
    1