BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1060375 · Received June 11, 2008

    Report

    Report Number
    2182269-2008-00153
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    April 15, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. A REVIEW OF THE LOT HISTORY WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NA 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE COMMON FEMORAL ARTERY. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. ALL OF THE SELECTION CRITERIA WERE MET AND DEPLOYMENT WAS SUCCESSFUL. APPROX 1 HR POST DEPLOYMENT, THE PT HAD AN OCCLUDED FEMORAL ARTERY. THE PHYSICIAN THOUGHT THERE MAY HAVE BEEN A DISSECTION ABOVE WHERE THE ANGIO-SEAL DEVICE HAD BEEN DEPLOYED. THE PHYSICIAN STATED THAT THE ANGIO-SEAL WAS IN THE CORRECT LOCATION. THE PT WAS TAKEN TO SURGERY WHERE THE ARTERY WAS REPAIRED. THE PHYSICIAN THEN CONFIRMED THAT THE BELIEVED THE DISSECTION AND OCCLUSION WERE NOT CAUSED BY THE ANGIO-SEAL DEVICE. THE PT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention