BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2862331 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07780
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 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: 7FR MACH1 AL1; CORSAIR MICRO CATHETER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, 99% RESTENOSED MID TO DISTAL RIGHT CORONARY ARTERY (RCA), A NON-ABBOTT GUIDE WIRE WAS DELIVERED WITH A NON-ABBOTT MICRO CATHETER AND THE GUIDE WIRE WAS EXCHANGED TWICE FOR NON-ABBOTT GUIDE WIRES. IT WAS NOTED THAT THE MICRO CATHETER WAS DELIVERED TOWARD THE SHORT AREA OF THE BIFURCATION OF THE ANTERIOR AND POSTERIOR DESCENDING VESSELS. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED THROUGH THE MICRO CATHETER; THE GUIDE WIRE WAS EXCHANGED TO THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE AND WAS DELIVERED TO THE ANTERIOR DESCENDING VESSEL. THE BMW ELITE WAS TO BE EXCHANGED; HOWEVER, WHEN THE DEVICE WAS BEING REMOVED IT BECAME STUCK WITH THE MICRO CATHETER AT APPROXIMATELY 3 CM PROXIMAL TO THE TIP. THE TWO DEVICES WERE REMOVED AS A SINGLE UNIT FROM THE ANATOMY WITHOUT ISSUE. IT WAS NOTED THAT THERE WAS NO RESISTANCE PRIOR TO THE DEVICES BECOMING STUCK. A SECOND NON-ABBOTT MICRO CATHETER AND A NON-ABBOTT GUIDE WIRE WERE DELIVERED AND BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 2100401

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES