BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2073319 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03043
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE FIRST BMW GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. THE GUIDE WIRE AND THE STENT DELIVERY SYSTEM WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, ALL GUIDE WIRES ARE VISUALLY INSPECTED FOR DAMAGE DURING MANUFACTURING AND PERFORMS OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, A 2.5 X 15 NON-ABBOTT DEVICE WAS USED TO PERFORM PRE-DILATATION. A 3.5 X 12 OTW XIENCE V STENT SYSTEM WAS ADVANCED ON THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMW) GUIDE WIRE BUT STICKING WAS FELT. THE STENT SYSTEM WAS WITHDRAWN AND STICKING WAS FELT DURING REMOVAL. THE BMW GUIDE WIRE WAS REMOVED FROM THE ANATOMY AND EXCHANGED FOR A NEW BMW OF THE SAME SIZE. THE SAME XIENCE STENT SYSTEM WAS ADVANCED ON THE GUIDE WIRE BUT STICKING WAS FELT. THE STENT SYSTEM WAS REMOVED FROM THE GUIDE WIRE AND STICKING WAS FELT. THE BMW GUIDE WIRE WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A GRAND SLAM GUIDE WIRE. THE SAME XIENCE STENT SYSTEM WAS ADVANCED SUCCESSFULLY OVER THE GUIDE WIRE AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO 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 0110271

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR STENT: 3.5X12 OTW XIENCE V