BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2882646 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08234
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 7, 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). 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. IT SHOULD BE NOTED THE HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE INSTRUCTIONS FOR USE STATES: DO NOT PUSH, AUGER, WITHDRAW, OR TORQUE IF THE TIP IS NOT MANEUVERABLE, OR IT BECOMES ENTRAPPED WITHIN THE VASCULATURE AND THIS DEVICE MEETS RESISTANCE. DETERMINE THE CAUSE OF RESISTANCE AND TAKE APPROPRIATE REMEDIAL ACTION AS NEEDED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE FAILED TO CROSS A MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE BMW ELITE WAS WITHDRAWN FROM THE ANATOMY AND A NON-ABBOTT GUIDE WIRE THEN CROSSED THE LESION, FOLLOWED BY ADVANCEMENT OF A NON-ABBOTT MICRO CATHETER OVER THE NON-ABBOTT GUIDE WIRE. WITH THE NON-ABBOTT MICRO CATHETER REMAINING IN THE ANATOMY, THE NON-ABBOTT GUIDE WIRE WAS THEN REPLACED WITH THE SAME BMW ELITE, HOWEVER, RESISTANCE WAS FELT BETWEEN A NON-ABBOTT MICRO CATHETER AND THE BMW ELITE GUIDE WIRE WHEN ADVANCING THE BMW ELITE INTO THE MICRO CATHETER, ONCE THE GUIDE WIRE TIP EXTENDED APPROXIMATELY 40 MILLIMETERS PAST THE DISTAL END OF THE MICRO CATHETER. THE BMW ELITE GUIDE WIRE WAS THEN REMOVED WITH RESISTANCE FELT BETWEEN THE TWO DEVICES, THUS, SLIGHT FORCE WAS APPLIED WHILE WITHDRAWING THE BMW ELITE. A NON-ABBOTT GUIDE WIRE WAS USED WITH THE MICRO CATHETER IN COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2100901

    Patients

    Seq Age Sex Outcome Treatment
    1 ASAHI CORSAIR MICRO CATHETER