BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2855135 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07652
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Adverse Event
    Yes
    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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A DE NOVO, CONCENTRIC LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS, A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED TO THE RCA BUT COULD NOT CROSS BY ITSELF. REPORTEDLY, A NON-ABBOTT MICRO CATHETER WAS USED TO SUPPORT THE BMW ELITE GUIDE WIRE. DURING ADVANCEMENT OF THE BMW ELITE GUIDE WIRE, RESISTANCE WAS MET INSIDE OF THE NON-ABBOTT GUIDING CATHETER BUT THE BMW ELITE WAS ABLE TO CROSS THE LESION BY PUSHING THE NON-ABBOTT MICRO CATHETER. REPORTEDLY, RESISTANCE WAS FELT INSIDE OF THE NON-ABBOTT GUIDING CATHETER DURING WITHDRAWAL OF THE BMW ELITE GUIDE WIRE. THE BMW ELITE GUIDE WIRE WAS STUCK IN THE NON-ABBOTT MICRO CATHETER; HOWEVER, IT WAS ABLE TO BE REMOVED FROM THE PATIENT ANATOMY USING A DOC EXTENSION. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND A 2.0X13 NON-ABBOTT DILATATION CATHETER WAS USED FOR PRE-DILATATION. A 3.0X15 XIENCE PRIME STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED WITH A 2.5X12 NC TREK WITHOUT ANY ISSUE TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND 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 2091801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: AXESS JR4.0OTHER: MOGUL