BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3041626 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02088
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 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
    BR
    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 NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTO OF THE DAMAGE WAS SENT TO THE MANUFACTURE. THE REPORTED COMPLAINT RELATED TO THE DAMAGED GUIDE WIRE IDENTIFIER WAS CONFIRMED BY THE PHOTO SENT, SHOWING THE WIRE IDENTIFIER WAS TORN AT THE PROXIMAL END. THERE WAS NO DAMAGE REPORTED UPON INITIAL USE AND NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE. IT IS LIKELY THAT THE MULTIPLE USE AND INTERACTIONS WITH DEVICES CONTRIBUTED TO THE GUIDE WIRE IDENTIFIER TEARING. WHILE A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT DEFICIENCY RELATED TO GUIDE WIRE IDENTIFIERS WAS NOTED. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE HAVE BEEN CONDUCTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CIRCUMFLEX ARTERY, THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS PLACED AND A BALLOON DILATATION WAS COMPLETED FOR PRE-DILATATION OF THE LESION. THE YELLOW WIRE IDENTIFIER WAS SPLIT/SEPARATED. THE UNSPECIFIED STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED ONTO THE PROXIMAL END OF THE GUIDE WIRE BUT THE YELLOW POLYMER GUIDE WIRE IDENTIFIER SLEEVE [PROXIMAL END] LIFTED AND SPLIT/SEPARATED [NOT DETACHED] PREVENTING ADVANCEMENT OF THE SDS. THIS OCCURRED OUTSIDE THE ANATOMY PRIOR TO THE RHV. THERE WAS NO REPORTED ISSUE WITH RESISTANCE/REMOVAL OF THE SDS. 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
    143857 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2042301

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR