BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1203025 · Received October 17, 2008

    Report

    Report Number
    2953144-2008-01694
    Event Type
    Death
    Date Received
    October 17, 2008
    Report Date
    September 24, 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
    UK
    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. DEVICE CODE: 1670: (AGAINST IFU): THE STARCLOSE INSTRUCTIONS FOR USE (IFU) CLOSURE PROCEDURE: STEP 2 "PERFORM A FEMORAL ANGIOGRAM THROUGH THE SIDE PORT OF THE PROCEDURAL SHEATH TO DETERMINE THE LOCATION OF THE ARTERIOTOMY SITE, THE VESSEL SIZE, AND THE PRESENCE OF DISEASE (CALCIFIED PLAQUE, STENOSIS, CHRONIC OR ACUTE OCCLUSION,) TORTUOSITY OR PRESENCE OF ARTERIAL WALL DISSECTION." DEVICE: (AGAINST IFU): THE STARCLOSE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS "DO NOT USE THE STARCLOSE VASCULAR CLOSURE SYSTEM TO CLOSE VESSELS WITH DIAMETERS LESS THAN 5 MM."

    Description of Event or Problem · 1

    REPORTED EVENT: VESSEL LOCATOR WINGS DAMAGED VESSEL. TIME OF REPORTED EVENT: DURING VESSEL CLOSURE. SYMPTOMS/AE: DEATH. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SIZE OF THE ARTERY WAS MISJUDGED AND THE VESSEL LOCATOR WINGS INJURED THE INTIMA OF THE ARTERY. DETAILS REGARDING THE EVENT AND SUBSEQUENT TREATMENT HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME. THE PT REPORTEDLY EXPIRED. THE CAUSE AND TIME OF DEATH WAS NOT PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 70 YR Death