BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1764484 · Received July 16, 2010

    Report

    Report Number
    2024168-2010-01411
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HI-TORQUE BMW (PART# 1009660, LOT 0032475), INDICATED IS BEING FILED UNDER A SEPARATE MFR #. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS REPORTED. A REVIEW OF DEVICE HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: SEPARATED GUIDE WIRE TIP. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: TIP COMPRESSED TO VESSEL WALL WITH A STENT. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT (BMW) WAS PLACED IN THE HEAVILY CALCIFIED CIRCUMFLEX (CX) BRANCH OF THE LEFT CORONARY ARTERY AND AFTER THE STENTING, DURING AN ATTEMPT TO REMOVE THE GUIDE WIRE, THERE WAS RESISTANCE AND THE GUIDE WIRE SEPARATED. THIS OCCURRED WITH TWO BMW GUIDE WIRES IN ONE PT. ONE OF THE SEPARATED GUIDE WIRE TIPS WAS COMPRESSING AGAINST THE VESSEL WALL WITH A NON-ABBOTT STENT AND THE OTHER WAS LEFT IN THE PT'S ANATOMY UNTREATED. THE PT IS DOING WELL AND WILL RECEIVE ANTICOAGULATION MEDICATION (3 AGENTS) FOR THE DURATION OF 12 MONTHS AND ON THE 13TH MONTH, THE PT WILL RECEIVE ONLY TWO AGENTS. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0032475

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention| S GUIDE WIRE: HI-TORQUE BMW| (PART 1009660, LOT 0032475)