BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 2181917 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03399
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    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; 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS PROXIMAL TO DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 185CM KINETIX GUIDE WIRE TO THE LESION USING A NON-BSC GUIDE CATHETER. THE GUIDE WIRE WAS THEN CONNECTED TO AN ADDWIRE EXTENSION WIRE. UPON REMOVAL THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE CATHETER FROM THE GUIDE WIRE. THE CATHETER AND GUIDE WIRES WERE REMOVED TOGETHER AS ONE UNIT AND THE GUIDE WIRES WERE KINKED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 13727312

    Patients

    Seq Age Sex Outcome Treatment
    1 FINECROSS GUIDE CATHETER| 6FR RADIOFOCUS INTRODUCER SHEATH| ADDWIRE EXTENSION WIRE