BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1032346 · Received April 22, 2008

    Report

    Report Number
    2953144-2008-00773
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PT AND DEVICE INFO. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO REMOVE AND WING BREAKAGE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: DETACHED WING PIECE UNRETRIEVED FROM THE BODY. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THE DEVICE BECAME STUCK IN THE PT'S ARTERY. THE DEVICE WAS REMOVED USING COUNTER-TENSION AND HEMOSTASIS WAS ACHIEVED. AFTER THE DEVICE WAS REMOVED, IT WAS FOUND THAT PART OF THE VESSEL LOCATOR WING WAS MISSING. THE PHYSICIAN PERFORMED FLUOROSCOPY AND FOUND THE BROKEN PIECE LOCATED INSIDE THE DEPLOYED CLIP. THE BROKEN PIECE REMAINS IN THE PT; NO ADVERSE PT EFFECTS WERE REPORTED. 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 63007-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other