BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 363364 · Received November 30, 2001

    Report

    Report Number
    2182269-2001-00113
    Event Type
    Injury
    Date Received
    November 30, 2001
    Date of Event
    July 1, 2001
    Report Date
    November 30, 2001
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING DEPLOYMENT OF THE ANGIO-SEAL DEVICE ON A PATIENT WITH PERIPHERAL VASCULAR DISEASE (PVD), COLLAGEN WAS NOTED ABOVE THE SKIN. THE PT DEVELOPED LOSS OF SENSATION IN THE LOWER LEG BELOW THE ARTERIOTOMY SITE AND THEN TRANSFERRED TO SURGERY. THE OUTCOME OF THE SURGERY WAS UNKNOWN. THE SENIOR CHIEF NURSE STATED THAT THE EVENT WAS NOT DEVICE RELATED AND SUGGESTED THAT THE PT WAS NOT A CANDIDATE FOR THE DEVICE DUE TO THE PRE-EXISTING PVD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54068 ANGIO-SEAL VASCULAR CLOSURE DEVICE ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL, DAIG DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention