BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2073339 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03049
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 4, 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. 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 BALLOON CATHETER 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. LOT HISTORY RECORD REVIEW DID NOT REVEAL ANY 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 THIS LOT. 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 WHEN ATTEMPTING TO ADVANCE THE 2.5 X 15 RX TREK DILATATION CATHETER OVER THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE OUTSIDE OF THE ANATOMY ON THE TABLE DURING DEVICE PREPARATION, STICKING WAS FELT. THE DILATATION CATHETER WAS REMOVED FROM THE GUIDE WIRE AND STICKING WAS FELT. THE GUIDE WIRE WAS EXCHANGED FOR A PROWATER GUIDE WIRE AND THE SAME TREK DILATATION CATHETER WAS ADVANCED AND REMOVED WITHOUT RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE.

    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 1030873

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: 2.5X15 RX TREK