BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1991563 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00189
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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: (B)(6). DEVICE EVALUATED 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

    SAME CASE AS MFR# 2134265-2011-00190. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE WITHDRAWAL DIFFICULTY OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 325CM ROTAWIRE GUIDE WIRE WAS ADVANCED TO THE LESION FOLLOWED BY A 3.00X20MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS); HOWEVER, THE TWO DEVICES BECAME STUCK TOGETHER DURING THE ADVANCEMENT OF THE SDS. AS THE PHYSICIAN WAS REMOVING THE DEVICES FROM THE PATIENT IT WAS NOTED THAT WITHDRAWAL RESISTANCE WAS ENCOUNTERED. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT FROM THE PATIENT AND IT WAS NOTED THAT THERE WAS A KINK ON THE SHAFT OF THE TAXUS LIBERTE SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020 13320515

    Patients

    Seq Age Sex Outcome Treatment
    1 3.0X20MM TAXUS LIBERTE STENT