BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1153272 · Received September 5, 2008

    Report

    Report Number
    2953144-2008-01456
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    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: TISSUE NOT IN COMPLETE APPOSITION. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE AT ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER SUTURE DEPLOYMENT AND KNOT ADVANCEMENT BLEEDING CONTINUED. A 9F SHEATH WAS INSERTED TO CONTROL THE BLEEDING AND THE ARTERY WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. THE SURGERY REVEALED THE VESSEL TISSUE WAS NOT IN COMPLETE APPOSITION. ADDITIONALLY, THE COMMON FEMORAL ARTERY WAS PUNCTURED ONE HOUR EARLIER WITH UNEVENTFUL ARTERIOTOMY. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED WAS NEGATIVE FOR RETROPERITONEAL BLEEDING. THE PT WAS DISCHARGED TO HOME THE NEXT DAY WITH COMPLETE RESOLUTION. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS 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 67 YR Required Intervention