BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 697844 · Received April 7, 2006

    Report

    Report Number
    2953144-2006-00061
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    March 9, 2006
    Report Date
    March 10, 2006
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED AN ARTERIOTOMY CLOSURE USING THE STARCLOSE DEVICE AFTER AN UNSPECIFIED INTERVENTIONAL PROCEDURE. HEMOSTASIS WAS REPORTEDLY ACHIEVED WITH THE STARCLOSE DEVICE. A FEMORAL ANGIOGRAM WAS DONE WITH THE FOLLOWING RESULTS REPORTED: "MIF FEMORAL COMMON, FEMORAL STICK, LARGE VESSEL, NO BRANCHES, CLEAN STICK." VESSEL CALCIFICATION AND PATENCY WERE NOT REPORTED. AT SOME UNDISCLOSED TIME AND PLACE, THE PT REPORTEDLY HAD A RETROPERITONEAL BLEED AND WAS TRANSFUSSED IN THE INTENSIVE CARE UNIT. THE UNITS OF BLOOD PRODUCTS USED, ANY ADDITONAL TREATMENTS OR HOSPITALIZATION WERE NOT RPEORTED. THE PT'S CURRENT CONDITION, AS WELL AS WHETHER SHE HAS BEEN DISCHARGED, WAS NOT REPORTED. IT WAS REPORTED THERE WERE NO DEATH ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R