BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3020018 · Received March 25, 2013

    Report

    Report Number
    2024168-2013-01701
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    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 DIFFICULT TO POSITION AND REMOVE WAS ABLE 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 PROCEDURE, A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED TO A LESION IN THE CIRCUMFLEX CORONARY ARTERY WITHOUT ISSUE. AFTER FLUSHING THE GUIDE WIRE LUMEN OF A 3.5X18 NON-ABBOTT STENT DELIVERY SYSTEM (SDS), IT WAS THEN ADVANCED OVER THE BMW ELITE, HOWEVER, THE SDS BECAME STUCK (WAS UNABLE TO BE ADVANCED OR RETRACTED) ON THE BMW ELITE, APPROXIMATELY 20 CENTIMETERS PROXIMAL TO THE DISTAL END OF THE BMW ELITE GUIDE WIRE. BOTH THE BMW ELITE AND SDS WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. THE SAME SDS WAS ABLE TO BE ADVANCED OVER A NON-ABBOTT GUIDE WIRE 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
    122494 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2110601

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 3.5X18 S-STENT