BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1251295 · Received December 3, 2008

    Report

    Report Number
    2953144-2008-01949
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 10, 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
    IT
    Reporter Occupation
    PHYSICIAN

    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: DIFFICULT TO REMOVE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT THE DEVICE WAS DIFFICULT TO REMOVE. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE WITH THE DILATOR-ASSISTED PORTS BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED USING COUNTER-TRACTION AND AN ASSERTIVE PULL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention