BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1020272 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00192
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 5, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. 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: HEMATOMA/HYPOTENSION. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN IN TRAINING IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE AFTER AN INTERVENTIONAL PROCEDURE. THE INFO RECEIVED INDICATED THAT THE CLIP WAS DEPLOYED BUT SLIGHT OOZING FROM THE TISSUE TRACT OCCURRED. REPORTEDLY, THE PT REMAINED ANTICOAGULATED WITH INTEGRILIN FOR APPROX 4-5 HOURS AFTER THE PROCEDURE. A FEW HOURS POST VESSEL CLOSURE, THE PT BECAME HYPOTENSIVE AND A CT SCAN REVEALED A HEMATOMA "GOING UP TO THE ABDOMEN" AND A LONG RETROGRADE DISSECTION IN THE FEMORAL ARTERY WHICH STARTED NEAR THE CLIP. MULTIPLE BLOOD TRANSFUSIONS WERE GIVEN. NO TREATMENT WAS DONE FOR THE DISSECTION. THERE WERE NO ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L 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 HEPARIN| INTEGRILIN