BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3042400 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02087
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    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. CONCOMITANT PRODUCTS: GUIDE CATH: TAIGA EBU35; OTHER: MOGUL MICROCATHETER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY TORTUOUS, ECCENTRIC, MODERATELY CALCIFIED, DE NOVO 90% STENOSED, DE NOVO, DISTAL CIRCUMFLEX ARTERY, THE BALANCE MIDDLEWEIGHT BMW ELITE GUIDE WIRE WAS DELIVERED WITH THE SUPPORT OF A NON-ABBOTT MICROCATHETER. AN ATTEMPT WAS MADE TO ADVANCE INTO THE TRUE VESSEL LUMEN BUT THE GUIDE WIRE TIP SHAPE WAS NOT APPROPRIATELY CURVED AND THE BMW ELITE WAS PULLED TO BE REMOVED. IT WAS NOTED THE TIP OF THE MICROCATHETER GOT STUCK WITH THE BMW ELITE ABOUT 3 CM PROXIMAL TO THE DISTAL END OF THE GUIDE WIRE. THE TWO DEVICES WERE REMOVED AS A SYSTEM FROM THE ANATOMY. OUTSIDE THE ANATOMY THE BMW ELITE TIP WAS HEAVILY WEAKENED AND BENT. A DIFFERENT NON-ABBOTT GUIDE WIRE WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147015 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2092801

    Patients

    Seq Age Sex Outcome Treatment
    1