BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATB ADVANCE

    MDR report key: 1570019 · Received December 28, 2009

    Report

    Report Number
    1570019
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 28, 2009
    Manufacturer
    COOK VASCULAR, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    AFTER PRE-DILATING THE SUPERIOR VENA CAVA (SVC), A WALL STENT WAS PLACED AT THE DESIRED SITE. UPON POST-DILATATION OF THE STENT THE ATB ADVANCE BALLOON RUPTURED. AS THE BALLOON WAS BEING REMOVED A PORTION CAUGHT ON THE STENT'S STRUT. A SNARE WAS THEN USED TO REMOVE THE RUPTURED BALLOON FRAGMENT AND A PORTION OF THE CATHETER WHICH ALSO BROKE OFF. THE TENT WAS THEN RETRIEVED AND LEFT IN THE RIGHT COMMON ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATB ADVANCE CATHETER, DILATION LIT COOK VASCULAR, INC. 644145 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR