BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1973259 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00547
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 10, 2011
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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 IN TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. ABOUT 4-5 DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF GROIN PAIN WHICH WAS DIAGNOSED AS ACCESS SITE ABCESS WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) POST PERCLOSE CLOSURE AND A SMALL FEMORAL ARTERY PSEUDOANEURYSM. ARTERIAL VEIN PATCH REPAIR AND EXTENSIVE DEBRIDEMENT OF INFECTED SOFT TISSUE WAS PERFORMED FOLLOWED BY A FIVE DAY HOSPITALIZATION AND DISCHARGE TO REHABILITATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R