BEUDAMED
    FDA Adverse Event Death Summary report: N

    STANDARD MICRO INTRODUCER KIT

    MDR report key: 2171515 · Received June 17, 2011

    Report

    Report Number
    1319211-2011-00056
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    PMA / PMN Number
    K080400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE USED 5F MICRO INTRODUCER 45CM GUIDEWIRE. A VISUAL REVIEW OF THE DEVICE NOTED THAT THE COILED TIP WAS TIED IN A KNOT. A VISUAL REVIEW NOTED NO DAMAGE TO THE WELDED TIP OR THE COILS OF THE GUIDEWIRE. A VISUAL REVIEW OF THE COILS UNDER A MICROSCOPE NOTED NO DEFECTS. THE FOLLOWING MEASUREMENTS WERE TAKEN AND FOUND TO BE WITHIN SPECIFICATIONS: COIL WIRE LENGTH AND PLASMA ARC WELD TIP RADIUS. THE COMPLAINT CANNOT BE CONFIRMED AS THE RETURNED DEVICE MET SPECIFICATIONS. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS TORTUOUS ANATOMY OF THE PATIENT. THERE IS NOTHING IN THE MANUFACTURING OR PACKAGING PROCESS THAT WOULD EXPLAIN THE CONDITION OF THE RETURNED DEVICE. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, INSTRUCTS THE END USER TO WITHDRAW THE ENTRY NEEDLE WHILE LEAVING THE 0.018" GUIDEWIRE IN PLACE. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2011 VIA MEDWATCH (B)(4), (B)(6) YEAR OLD FEMALE ADMITTED FOR THROMBOSED ARTERIOVENOUS GRAFT. SHE HAD A HISTORY OF END STAGE RENAL DISEASE AND CONGESTIVE CARDIOMYOPATHY. WHILE THE VASCULAR SURGEON WAS PERFORMING THE PERCUTANEOUS MECHANICAL THROMBECTOMY OF THE AV GRAFT, THE STAINLESS STEEL MIRCO INTRODUCER WIRE COILED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS PRODUCT PROBLEM. THE VASCULAR SURGEON USED ANOTHER OF THE SAME DEVICE TO CONTINUE ON WITH THE PROCEDURE. THE PROCEDURE WAS TERMINATED AS THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT EXPIRED SIX (6) DAYS POST PROCEDURE. IT IS THE OPINION OF THE VASCULAR SURGEON WHO PERFORMED THE PROCEDURE THAT THE MYOCARDIAL INFARCTION WAS TOTALLY UNRELATED TO THE REPORTED PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD MICRO INTRODUCER KIT GUIDEWIRE DQX ANGIODYNAMICS NA 535822

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death