BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2933364 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00451
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). RESISTANCE WAS ENCOUNTERED WHEN A NON-ABBOTT BALLOON WAS ADVANCED OVER THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMW UII) GUIDE WIRE. THE BALLOON WAS ATTEMPTED TO BE RETRACTED, HOWEVER, RESISTANCE WAS ALSO ENCOUNTERED DURING RETRACTION. THE DEVICES WERE WITHDRAWN FROM THE ANATOMY AS A UNIT. THE VESSEL WAS RE-WIRED AND A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39695 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR DIL CATH: BOSTON SCIENTIFIC QUANTUM