BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1111536 · Received August 13, 2008

    Report

    Report Number
    2953144-2008-01316
    Event Type
    Injury
    Date Received
    August 13, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: KNOT LOOSE, UNTIED OR DIFFICULT TO DEPLOY THE KNOT. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN'S ASSISTANT ATTEMPTED ARTERIOTOMY CLOSURE OF UNSPECIFIED ARTERIES USING THE PERCLOSE AT DEVICE AFTER UNSPECIFIED PROCEDURES. REPORTEDLY, THE EVENTS WERE A MIX OF 'LOOSE KNOT", "DIFFICULTY TO DEPLOY THE KNOT" OR "ONLY ONE SIDE OF THE SUTURE WAS TIED". NO SPECIFIC NUMBER OF DEVICES PER EVENT, OR PROCEDURES, WERE IDENTIFIED. HEMOSTASIS WAS ACHIEVED BY UNKNOWN METHODS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention