BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2911422 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00245
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT RELATED TO THE GUIDE WIRE IDENTIFIER PEELING WAS CONFIRMED, WITH 4MM MISSING FROM THE DISTAL END. THE SEPARATED PORTION WAS NOT RETURNED. THERE WERE OFFSET COILS PROXIMAL TO THE MARKER FOR A LENGTH OF 1.5MM. THE OUTER DIAMETERS OF THE GUIDE WIRE WERE MEASURED AND MET MANUFACTURING CRITERIA. IT WAS REPORTED THAT THE GUIDE WIRE WAS USED 3 TIMES IN THE PROCEDURE WITH ANOTHER DEVICES WITH NO DIFFICULTIES NOTED AND THERE WAS 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 PEELING 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 THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE PROXIMAL YELLOW IDENTIFIER PEELED OFF THREE TIMES WHEN THE BALLOON DILATATION CATHETER WAS ADVANCED. THE BMW WAS REPLACED WITH A BMW UNIVERSAL II GUIDE WIRE. 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
    16726 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1101001

    Patients

    Seq Age Sex Outcome Treatment
    1