BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842243 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01936
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    May 29, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE SUPERFICIAL FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AS THE DEVICE WAS ADVANCED IN THE SKIN TRACT, RESISTANCE WAS FELT AND THE SHAFT COULD NOT BE ADVANCED. THE DEVICE WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention