BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2020870 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01783
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. (AGE AT TIME OF EVENT): IS THE ESTIMATED AGE OF THE PATIENT WHO WAS REPORTED AS BEING IN HIS SIXTIES. (DATE OF EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED SOMETIME THE WEEK PRIOR FROM THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS THE BEST ESTIMATE DATE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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 THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE CLIP DID NOT DEPLOY AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. UPON DEVICE REMOVAL, IT WAS NOTICED THAT THE SHEATH HAD NOT SPLIT COMPLETELY AND THE WINGS WERE IN THE CLOSED POSITION. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 950136H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention HEPARIN.