BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2033041 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02145
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. (B)(6). THE FACILITY REPORTER INDICATED THE EVENT OCCURRED TWO WEEKS PRIOR FROM THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS ESTIMATED DATE. 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 PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING DEVICE DEPLOYMENT, WHEN THE PLUNGER WAS RETRACTED THERE WAS NO SUTURE PRESENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE AND IT BECAME STUCK IN THE PATIENT'S GROIN. A CUT DOWN WAS PERFORMED TO RELEASE THE DEVICE AND ONCE IT WAS REMOVED THE ARTERY WAS SUTURED. DURING DEVICE INSPECTION IT WAS NOTICED THAT THE SHEATH WAS ACCORDIONED AND FOLDED INSIDE OF ITSELF. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SHEATH: 8FR. OTHER: ANGIOMAX.