BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 3834006 · Received May 27, 2014

    Report

    Report Number
    2024168-2014-03354
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INDICATION FOR USE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE WAS USED TO TREAT THE INTERNAL CAROTID ARTERY. IT SHOULD BE NOTED THAT THE INSTRUCTION FOR USE (IFU) STATES: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). IN THIS CASE, IT COULD NOT BE DETERMINED IF USING THE GUIDE WIRE IN THE CAROTID CONTRIBUTED TO THE DIFFICULTIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE 70% STENOSED INTERNAL CAROTID ARTERY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CAROTID ARTERY. A NON-ABBOTT STENT AND A NON-ABBOTT BALLOON WERE USED SUCCESSFULLY WITH A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE. WHEN THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE TIP WAS SEPARATED. THE SEPARATED TIP WAS FOUND IN THE GUIDING CATHETER. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311378 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 3121772

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR