BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK? PLUS

    MDR report key: 3912327 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03874
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS: 2134265-2014-03875. IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. THE 90% STENOSED, 10 TO 15MM IN LENGTH AND 3.0MM IN DIAMETER TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END OF LATERAL CIRCUMFLEX ARTERY. A 1.25MM ROTALINK PLUS AND A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE, THE PHYSICIAN SET THE ROTATION SPEED OF THE BURR AT 220,000 TO 230,000RPM. THE SPEED DECREASED TO 10,000RPM DURING USE DUE TO DIFFICULTY CROSSING THE LESION. IT WAS NOTED DURING ABLATION THAT THE PROXIMAL END OF THE STENT AND THE BURR CAME INTO CONTACT WITH THE VESSEL WALL CAUSING IT TO BLEED. BLEEDING WAS STOPPED BY INFLATION USING A NON BSC BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390644 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention