BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1833195 · Received September 9, 2010

    Report

    Report Number
    2953144-2010-01892
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 18, 2010
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER THE PROCEDURE, THE PT DEVELOPED RIGHT LEG PAIN AND HAD NO PULSE IN THE LEG. AN ANGIOGRAM PERFORMED REVEALED A COMPLETE OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY AND DISTAL RUN-OFF. EMERGENT EXPLORATORY SURGERY REVEALED THAT THE STARCLOSE SE DEVICE CLIP HAD CAUGHT THE BACK WALL OF THE ARTERY. THE CLIP WAS REMOVED AND THE VESSEL WAS SURGICALLY REPAIRED AND SUTURED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADD'L 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 Required Intervention