BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 4528312 · Received February 19, 2015

    Report

    Report Number
    2024168-2015-00867
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 26, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE COMPLAINT 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. 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. IN ADDITION, 20 UNUSED, STERILE BALANCE MIDDLE-WEIGHT GUIDE WIRES WITH THE SAME PART AND LOT NUMBER (1001780JS / 4100371) AS THE COMPLAINT DEVICE WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. THE UNUSED RETURNED DEVICES DID NOT SHOW ANY INDICATION OF DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RESISTANCE WITH THE BALANCE MIDDLE-WEIGHT GUIDE WIRE DURING ADVANCEMENT AND REMOVAL OF THE 2.5X20 TREK BALLOON FROM THE NON-TORTUOUS, NON-CALCIFIED RIGHT CORONARY ARTERY. THE CASE WAS COMPLETED AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119714 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 4100371

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR DILATATION CATHETER: 2.5X20 TREK