BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1131038 · Received August 21, 2008

    Report

    Report Number
    2953144-2008-01365
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: PSEUDOANEURYSM. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER A DIAGNOSTIC PROCEDURE. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. REPORTEDLY, APPROX 7 DAYS POST VESSEL CLOSURE, THE PT RETURNED TO THE PHYSICIAN'S OFFICE AND IT WAS NOTED THAT THE PT HAD EXPERIENCED A "VERY SMALL" PSEUDOANEURYSM. THE PHYSICIAN TRIED A "CLAMP" TO COMPRESS THE PSEUDOANEURYSM; HOWEVER, WAS UNSUCCESSFUL. THE PHYSICIAN SENT THE PT TO CONSULT WITH A SURGEON IN 2008. NO ADDITIONAL TREATMENT HAS BEEN REPORTED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE AND THE PT IS REPORTED AS DOING FINE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention