BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR AGILTRAC

    MDR report key: 1133449 · Received August 20, 2008

    Report

    Report Number
    1133449
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    March 11, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT OF THIS EVENT RECEIVED ON 08/18/2008. PROCEDURE - SUBCLAVIAN VENOGRAM AND SUPERIOR VENOGRAM, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF SUBCLAVIAN VEIN AND SUPERIOR VENA CAVA, REPEAT STENTING OF LEFT SUBCLAVIAN VEIN, AND PULMONARY ANGIOGRAM. DURING THE PROCEDURE, FURTHER BALLOON DILATATION WAS MET WITH THE RUPTURE OF THE 10MM BALLOON. THE BALLOON WAS PARTIALLY AVULSED, AND A PORTION OF THE BALLOON COULD NOT BE RETRIEVED. THE REMAINDER OF THE BALLOON WAS WITHDRAWN FROM THE BODY USING A GOOSENECK SNARE. SOME OF THE MATERIAL THAT MADE UP THE ACTUAL BALLOON ITSELF HAD AVULSED AND COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR AGILTRAC PERIPHERAL BALLOON 10.0X40MM 135CM LIT ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R