BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 3261510 · Received August 2, 2013

    Report

    Report Number
    2024168-2013-04848
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STRETCHED COILS WERE ABLE TO BE CONFIRMED. THE SHAPING RIBBON WAS SEPARATED FROM THE CENTER SOLDER AND STILL ATTACHED TO THE TIP BALL. BASED ON A VISUAL INSPECTION AND SEM IMAGING 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS USED WITH SEVERAL DEVICES THROUGHOUT THE PROCEDURE. THE GUIDE WIRE WAS REMOVED WITHOUT DIFFICULTY. UPON REMOVAL OF THE GUIDE WIRE, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE WAS UNRAVELING. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362469 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1