BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2882481 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08220
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE CATHETER WAS UNABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 THE PERCUTANEOUS TRANSLUMINAL INTERVENTION PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT MAIN CORONARY ARTERY WITH MILD TORTUOSITY, AFTER ADVANCING A NON-ABBOTT GUIDE WIRE PAST THE LESION, A NON-ABBOTT MICRO CATHETER WAS ADVANCED OVER THE GUIDE WIRE, BUT RESISTANCE WAS FELT DURING ADVANCEMENT. WITH THE NON-ABBOTT MICRO CATHETER REMAINING IN THE ANATOMY, THE GUIDE WIRE WAS EXCHANGED FOR A BALANCE MIDDLEWEIGHT (BMW) ELITE W/O MARKER GUIDE WIRE, AND THE BMW ELITE WAS ADVANCED PAST THE LESION. UPON WITHDRAWING THE BMW ELITE GUIDE WIRE FROM THE MICRO CATHETER, THE BMW ELITE BECAME STUCK INSIDE OF THE MICRO CATHETER APPROXIMATELY 10 CENTIMETERS PROXIMAL TO THE GUIDE WIRE TIP, BUT WAS ULTIMATELY ABLE TO BE WITHDRAWN ALONE, WITH THE MICRO CATHETER REMAINING IN THE ANATOMY. THE PROCEDURE WAS COMPLETED USING A NEW NON-ABBOTT GUIDE WIRE WITH THE MICRO CATHETER WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. 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 2092001

    Patients

    Seq Age Sex Outcome Treatment
    1 CORSAIR MICRO CATHETER