BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIFUSE INFUSION CATHETER

    MDR report key: 2348557 · Received August 22, 2011

    Report

    Report Number
    1319211-2011-00075
    Event Type
    Other
    Date Received
    August 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    KRA
    PMA / PMN Number
    K905447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED COMPLAINT SAMPLE WAS NOT RETURNED BY THE END USER, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THE CATHETER MIGRATION WAS MOST LIKELY CAUSED BY THE USERS' FAILURE TO PROPERLY SECURE THE CATHETER; HOWEVER THIS CANNOT BE DEFINITIVELY DETERMINED AT THIS TIME. THIS DEVICE IS MANUFACTURED WITH TWO RADIOPAQUE (R/O) MARKERS ON THE CATHETER SHAFT TO ASSIST THE USER WITH THE PLACEMENT AND LOCATION MONITORING OF THE CATHETER. THERE IS NO ALLEGATION THAT THE (R/O) MARKERS MALFUNCTIONED. A REVIEW OF THE ANGIODYNAMICS COMPLAINTS DATABASE NOTED THAT THIS IS THE FIRST REPORTED COMPLAINT FOR THIS COMPLAINT TYPE AND IT APPEARS THAT THIS IS AN ISOLATED INCIDENT. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE LOTS OBTAINED THROUGH A SHIP HISTORY REVIEW, 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 USER ON (B)(6) 2011 VIA USER MEDWATCH (B)(4) A (B)(6), MALE PATIENT PRESENTED FOR A LIMB SALVAGE PROCEDURE. AN UNIFUSE INFUSION CATHETER WAS USED TO INFUSE THROMBOLYTIC THERAPY. DURING THE PROCEDURE THE INFUSION CATHETER WAS FOUND INTACT AND UNDAMAGED BUT DISLODGED FROM TARGETED SITE WITH LOOP OF CATHETER OUT BY 28CM. THE USER HAS TWO SAFETY ISSUES; SAFETY ISSUES #1 - NO MARKERS ON CATHETER TO HELP HEALTHCARE PROVIDER DETERMINE HOW MUCH THE CATHETER HAS BEEN DISLODGED; SAFETY ISSUE #2 - UNABLE TO SUTURE OR AFFIX CATHETER SO THAT IT REMAINS IN PLACE FOR INFUSION THERAPY. THE USER FELT THIS EVENT WAS NOT ABSOLUTE CAUSE OF NEED FOR BELOW ELBOW AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFUSE INFUSION CATHETER INFUSION CATHETER KRA ANGIODYNAMICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| S