BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1162103 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02657
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT # 2134265-2008-02658. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, WIRE SEPARATION OCCURRED. THE SEVERELY CALCIFIED AND 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS CIRCUMFLEX (CX). EIGHTEEN ABLATIONS RUNS WERE PERFORMED FOR A TOTAL ABLATION TIME OF APPROX 5 MINS. NO DIFFICULTIES WERE NOTED DURING ABLATION. DURING REMOVAL IN DYNAGLIDE MODE, THE PHYSICIAN NOTED THAT THE DISTAL 10CM OF THE ROTAWIRE 325CM GUIDE WIRE WAS SHEARED OFF AND REMAINED INSIDE THE CX. ATTEMPTS WERE MADE TO SNARE THE GUIDE WIRE FRAGMENT; HOWEVER, THOSE ATTEMPTS WERE UNSUCCESSFUL. AN UNSPECIFIED STENT WAS THEN USED TO SECURE THE GUIDE WIRE FRAGMENT AGAINST THE WALL OF THE ARTERY, HOWEVER STENTING WAS PART OF THE ORIGINAL PLAN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. PT STATUS IS REPORTED AS 'FINE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION FLOPPY RTW

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other