BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2750747 · Received September 25, 2008

    Report

    Report Number
    2750747
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION WITH ANGIOPLASTY AND STENT PLACEMENT, THE STENT BALLOON BROKE OFF IN THE PT'S CORONARY ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BALLOON BY TRAPPING IT WITH A SECOND BALLOON INFLATED CATHETER. ABBOTT VASCULAR'S REP ((B)(4)) WAS NOTIFIED AND WAS GIVEN THE BROKEN DEVICE ON (B)(4) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR MULTILINK VISION STENT RX MAF ABBOTT VASCULAR 7021931

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention