BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSEM

    MDR report key: 1378461 · Received May 8, 2009

    Report

    Report Number
    2953144-2009-00512
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    April 13, 2009
    Report Date
    April 14, 2009
    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
    VA, US
    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. THE STAR CLOSE SE INSTRUCTIONS FOR USE (IFU) STATE: UNDER PRECAUTIONS SECTION, "THE STARCLOSE SE VASCULAR CLOSURE SYSTEM SHOULD BE USED ONLY BY OPERATORS TRAINED IN DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WHO HAVE BEEN CERTIFIED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR INC". ALSO, UNDER SPECIAL PATIENT POPULATIONS SECTION, THE IFU STATE, "THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH HYPERTENSION (SYSTOLIC BP > 180 MM HG OR DIASTOLIC BP > 110 MM HG) UNRESPONSIVE TO MEDICAL THERAPY".

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO ADEQUATELY DEPLOY-CLIP. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE OF ACHIEVE HEMOSTASIS, HEMATOMA. IT WAS REPORTED THAT A PHYSICIAN UNTRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP DID NOT ACHIEVE ADEQUATE ARTERIOTOMY CAPTURE AND A HEMATOMA DEVELOPED. MANUAL COMPRESSION WAS APPLIED TO EXPRESS THE HEMATOMA AND TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention