BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 277475 · Received May 12, 2000

    Report

    Report Number
    2182269-2000-00060
    Event Type
    Injury
    Date Received
    May 12, 2000
    Date of Event
    April 3, 2000
    Report Date
    May 12, 2000
    Manufacturer
    DAIG CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING AN ANTERIOGRAM OF THE RIGHT FEMORAL ARTERY, AN ANGIO-SEAL DEVICE WAS DEPLOYED. THE PT LATER EXPERIENCED A VESSEL OCCLUSION AND THE ANGIO-SEAL DEVICE WAS REMOVED THE SAME DAY. THE INTIIAL ARTERIOGRAM REVEALED THE VESSEL SITE WAS SMALL AND HAD PERIPHERAL VASCULAR DISEASE (PVD). THE VASCULAR SURGEON ALSO STATED THAT THERE WAS AN ECCENTRIC PLAQUE ON THE POSTERIR WALL OF THE RIGHT FEMEROAL ARTERY THAT WAS NOT VISIBLE DURING ANGIOGRAPHY. THE PHYSICIAN HAS INDICATED THAT THE PT WAS NOT A GOOD CANDIDATE FOR THE ANGIO-SEAL DEVICE DUE TO THE SMALL VESSEL SIZE IN CONJUCNTION WITH THE PVD WHICH RESULTED IN THE VESSEL OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE 8F ANGIO-SEAL MGB DAIG CORP. 610089 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention