BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE .018 SS

    MDR report key: 2070555 · Received March 29, 2011

    Report

    Report Number
    1319211-2011-00031
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    PMA / PMN Number
    K914986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WERE ONE USED NEEDLE AND ONE USED GUIDEWIRE. A VISUAL REVIEW OF THE NEEDLE NOTED NO DEFECTS. A 0.018" WIRE WAS OBTAINED FROM STOCK AND INSERTED THROUGH THE NEEDLE WITH NO ISSUE. THE NEEDLE WAS THEN PULLED BACK OVER THE WIRE. NO ISSUES WERE NOTED. A VISUAL REVIEW OF THE GUIDEWIRE NOTED THAT THE DISTAL TIP OF THE WIRE WAS MISSING AND THAT THE WIRE WAS UNCOILED FROM THE MANDREL. THE COMPLAINT IS CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE END USER PULLED THE GUIDEWIRE BACK THROUGH THE NEEDLE. THE WELD TIP OF THE GUIDEWIRE GOT CAUGHT ON THE BEVELED EDGE OF THE NEEDLE, CAUSING THE WIRE TO BECOME UNCOILED. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT: "ADVANCE THE 0.018" GUIDEWIRE THROUGH THE 21 GAUGE NEEDLE. WITHDRAW THE ENTRY NEEDLE WHILE LEAVING THE 0.018" GUIDEWIRE IN PLACE. ADVANCE THE MICRO-INTRODUCER OVER THE 0.018" GUIDEWIRE. REMOVE THE 0.018" GUIDEWIRE AND THE MICRO-INTRODUCER INNER DILATOR." THIS DEVICE RECEIVES A 100% VISUAL INSPECTION AND AQL INSPECTION DURING THE MANUFACTURING PROCESS FOR THIS COMPLAINT TYPE. 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 PRODUCT FAMILY AND COMPLAINT TYPE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER, "THE WIRE WOULD NOT EXIT THE NEEDLE WHEN PULLED THROUGH. THE WIRE APPEARED TO HAVE A BURR AT THE WELD AND WOULD NOT EXIT THROUGH THE NEEDLE." THE WIRE BROKE IN THE NEEDLE AND MIGRATED INTO THE PATIENT. THE WIRE REMNANT WAS SUCCESSFULLY RETRIEVED USING A SNARE. THERE WAS NO HARM TO THE PATIENT DUE TO THIS INCIDENT AND THE PATIENT IS DOING WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE .018 SS GUIDEWIRE DQX ANGIODYNAMICS NA 531613

    Patients

    Seq Age Sex Outcome Treatment
    1