BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2800042 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06639
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. (B)(4): AGAINST RESISTANCE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. HOWEVER, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE WARNINGS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE OR TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT THROUGH THE RADIAL ARTERY WITH THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, RESISTANCE WAS ENCOUNTERED CLOSE TO THE ELBOW AREA, DUE TO VESSEL TORTUOSITY. AFTER MAKING SEVERAL ATTEMPTS AND TORQUING THE GUIDE WIRE, IT WAS ABLE TO PASS THROUGH. HOWEVER, IT WAS NOTED THAT THE DISTAL PART OF THE GUIDE WIRE HAD SEPARATED. THE SEPARATED PORTION WAS RETRIEVED USING A SNARE VIA ACCESS FROM THE FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED AND THE FINAL RESULT WAS REPORTED TO BE GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2012671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention