BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2113849 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03879
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED BLOOD AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THE NON-ABBOTT Y CONNECTOR USED IN THE PROCEDURE WAS NOT RETURNED. ANALYSIS CONFIRMED THE REPORTED KINK IN THE GUIDE WIRE AS THERE WAS A KINK IN THE TIP PROXIMAL TO THE TIP BALL. THE NOTED KINK IN THE GUIDE WIRE APPEARS TO BE CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE AS NO DAMAGE WAS REPORTED DURING INSPECTION PRIOR TO USE. ANALYSIS COULD NOT CONFIRM THE REPORTED DIFFICULTY AS THE RETURNED GUIDE WIRE WAS ADVANCED THROUGH A NEW ROTATING HEMOSTATIC VALVE AT AN OPEN POSITION WITH NO RESISTANCE NOTED. THE OUTER DIAMETER OF THE SOLDER JOINTS OF THE GUIDE WIRE WAS MEASURED AND MET MANUFACTURING CRITERIA. THE OUTER DIAMETER OF THE GUIDE WIRE PROXIMAL TO THE HYPOTUBE WAS MEASURED AND MET MANUFACTURING CRITERIA. RESISTANCE BETWEEN DEVICES CAN OCCUR DUE TO NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, INTERACTION WITH OTHER DEVICES, INSERTION/REMOVAL/PREPARATION TECHNIQUE, AND/OR CONDITION OF WIRE COATING. COAGULATION OF BLOOD OR CONTRAST IN THE OTHER DEVICE OR ON THE WIRE CAN BE A FACTOR IN REDUCING CLEARANCE. THE GUIDE WIRE SHEATH AND THE COMPETITOR Y-CONNECTOR WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR DIFFICULTY REMOVING THE GUIDE WIRE FROM OTHER DEVICE AND A KINK IN THE GUIDE WIRE FOR THIS PART AND LOT COMBINATION. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DIFFICULTY AND THE REPORTED KINK IN THE GUIDE WIRE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIP AFTER IT IS LOADED INTO THE DISPENSER AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING ARTERY THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMW) GUIDE WIRE BECAME 'STUCK' AT THE NON-ABBOTT Y-CONNECTOR DURING REMOVAL FROM THE ANATOMY. THE GUIDE WIRE WAS SUCCESSFULLY REMOVED AND A SECOND NON-ABBOTT GUIDE WIRE WAS USED IN THE PROCEDURE. IT WAS NOTED AFTER REMOVAL THAT THE GUIDE WIRE SURFACE APPEARED BENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 1013171

    Patients

    Seq Age Sex Outcome Treatment
    1 RHV: OKAY II/GOODMAN