BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2882729 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08238
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    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. THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE CATHETER WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED;

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, CONCENTRIC, HEAVILY CALCIFIED, 99% STENOSED, MID LEFT ANTERIOR DESCENDING ARTERY, THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED WITH A NON-ABBOTT MICRO CATHETER. THE GUIDE WIRE WAS UNABLE TO BE TORQUED WHEN CROSSING THE LESION; THEN THE GUIDE WIRE COULD NOT BE REMOVED FROM THE MICRO CATHETER. THE TWO DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. A NON-ABBOTT GUIDE WIRE AND THE SAME MICRO CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2100801

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR OTHER: MOGUL