BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2914344 · Received January 14, 2013

    Report

    Report Number
    2024168-2013-00282
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE CATH: MACH1; STENT: XIENCE PRIME. IT IS INDICATED THAT THE 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. THE XIENCE PRIME, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC, 100% CHRONIC TOTALLY OCCLUDED, NON-DE NOVO, DISTAL RIGHT CORONARY ARTERY (RCA), THE 2.5 X 33 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCING OVER THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE AND BECAME STUCK. THE DEVICES WERE REMOVED FROM THE ANATOMY AS ONE UNIT WITHOUT ISSUE. OUTSIDE THE ANATOMY THE SDS WAS REMOVED FROM THE GUIDE WIRE. A SECOND XIENCE PRIME SDS WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21110 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2110601

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES