BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 1812640 · Received August 17, 2010

    Report

    Report Number
    2024168-2010-01689
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE ISSUE: GUIDE WIRE SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: SNARING OF SEPARATED GUIDE WIRE. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED SUPERFICIAL FEMORAL ARTERY, THE GUIDE WIRE WAS HEAVILY TORQUED REPEATEDLY, IN AN ATTEMPT TO CROSS A HEAVILY CALCIFIED LESION. THE GUIDE WIRE SEPARATED AND THE SEPARATED PORTION WAS RETRIEVED USING A SNARE. THE PHYSICIAN STATED THAT THE GUIDE WIRE MAY HAVE GOTTEN CAUGHT IN THE CALCIUM WHEN IT WAS REPEATED TORQUED DURING THE CROSSING ATTEMPT. NO PT EFFECTS WERE REPORTED. THERE IS NO ADDITIONAL EVENT OR PT INFORMATION AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention