BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 5032166 · Received August 26, 2015

    Report

    Report Number
    2134265-2015-05744
    Event Type
    Death
    Date Received
    August 26, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    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

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2015-05748. IT WAS REPORTED THAT A PERFORATION AND PATIENT DEATH OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL END OF THE LEFT CIRCUMFLEX ARTERY (LCX). THE ANGLE OF THE LESION WAS NOTED TO BE 90 DEGREES. A 1.5MM ROTALINK PLUS AND A 330CM ROTAWIRE WERE USED FOR TREATMENT. WHEN ADVANCING THE BURR, THE ROTAWIRE WAS DETACHED AND THE ROTALINK PLUS BURR PERFORATED THE VESSEL. A PERFUSION BALLOON WAS USED TO TREAT THE PERFORATION, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR SURGERY; HOWEVER, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564137 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R