BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2032937 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02134
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED AND THEREFORE A THOROUGH ANALYSIS COULD NOT BE PERFORMED. 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 ATTEMPTED ARTERIOTOMY CLOSURE OF A VESSEL SITE WHICH WAS LOCATED ABOVE THE INFERIOR EPIGASTIC ARTERY (IEA) AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE DEPLOYED UNEVENTFULLY AND HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS HOSPITALIZED OVERNIGHT. THE NEXT DAY, THE PATIENT WAS REPORTED TO BE HYPOTENSIVE AND WAS BLEEDING. SURGICAL INTERVENTION WAS REQUIRED. A HEMATOMA WAS OBSERVED AFTER SURGICAL EVACUATION WHICH CAUSED DUE TO RETRO PERINEAL BLEEDING. HEMOSTASIS WAS ACHIEVED BY SURGERY. PATIENT WAS REPORTED TO BE HOSPITALIZED BUT IS STABLE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R