BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842364 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01976
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    November 14, 2008
    Report Date
    June 15, 2009
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE 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 ACHIEVED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, POST-PROCEDURE, THE RIGHT GROIN WAS "MOIST WITH DRAINAGE". THE GROIN SITE WAS TREATED WITH LIDOCAINE AND EPINEPHRINE INJECTION AT 09:00 HRS. REASSESSMENT OF THE GROIN DRESSING AT 09:15 HRS FOUND IT WAS DRY AND INTACT. THE PT WAS REPORTED TO BE PRESCRIBED ANTICOAGULANTS OF ASPIRIN AND CLOPIDOGREL, WHICH MAY HAVE INFLUENCED THE TISSUE TRACT OOZING. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO 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 64 YR Other