BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2153708 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02840
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    THE SAME CASE AS: 2134265-2011-02886. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE GUIDE WIRE AND BURR GOT STUCK IN THE LESION. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOTIC, DE NOVO AND ECCENTRIC SHAPED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN CROSSED THE LESION WITH A 330CM ROTA FLOPPY GUIDE WIRE AND THEN ADVANCED THE 1.5MM ROTALINK BURR TO THE LESION AND IT WAS NOTED THAT THE ADVANCER WAS LEAKING. DURING ABLATION THE ROTAWIRE GUIDE WIRE AND ROTALINK BURR BECAME STUCK IN THE LESION. THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDE WIRE AND BURR SO THE PROCEDURE WAS STOPPED AND THE PATIENT WAS SENT FOR A CORONARY ARTERY BY-PASS GRAFT PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 14010020

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention JL4 6F| 330CM ROTA FLOPPY GUIDE WIRE| ROTALINK ADVANCER