BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2073338 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03050
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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. 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 COULD HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. 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. ALL GUIDE WIRES ARE 100 % VISUALLY INSPECTED FOR DAMAGE DURING MANUFACTURING AND PERFORMS 100% 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 THE PROCEDURE IN THE RIGHT POSTERIOR LATERAL BRANCH, A 2.5 X 15 MM OTW TREK DILATATION CATHETER WAS ADVANCED ON A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE. STICKING WAS FELT; HOWEVER, DILATATION WAS PERFORMED SUCCESSFULLY. DURING REMOVAL OF THE DILATATION CATHETER, STICKING WAS FELT AGAIN. A 2.5 X 23 MM OTW XIENCE V STENT SYSTEM WAS ADVANCED ON THE SAME BMW GUIDE WIRE AND STICKING WAS FELT; THEREFORE, THE STENT SYSTEM WAS REMOVED. THE BMW GUIDE WIRE WAS EXCHANGED FOR A PROWATER GUIDE WIRE AND THE SAME STENT SYSTEM WAS ADVANCED WITH SUCCESSFUL STENT DEPLOYMENT. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE STENT SYSTEM. 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 66 YR DIL CATH: 2.5X15 OTW TREKSTENT: 2.5X23 OTW XIENC