BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 4102951 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06061
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE BALANCE MIDDLEWEIGHT GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. 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 LOWER LIMB THE 0.014 BALANCE MIDDLEWEIGHT UNIVERSAL II (BMSUII) GUIDE WIRE WAS USED BUT WAS NOTED TO BE SEPARATED/BROKEN WHILE IN THE 4 FR UNSPECIFIED GUIDE CATHETER. THE GUIDE WIRE WAS REMOVED AND A SECOND BMWUII WAS USED BUT IT WAS NOTED THE GUIDE WIRE HAD SEPARATED/BROKE WHILE IN THE GUIDE CATHETER. THE SEPARATIONS WERE NOTED TO BE APPROXIMATELY 50 CM TO THE GUIDE WIRE TIP. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED ISSUE. 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
    583867 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 4030871

    Patients

    Seq Age Sex Outcome Treatment
    1