BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842245 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01933
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    November 19, 2008
    Report Date
    June 23, 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 WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, POST-PROCEDURE, THE GROIN DEVELOPED OOZING. AFTER THE SITE WAS INJECTED WITH EPINEPHRINE AND LIDOCAINE, PER HOSPITAL PROTOCOL, THE DRESSING WAS CHANGED, AND MANUAL PRESSURE WAS APPLIED WITH A SANDBAG; THE OOZING RESOLVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 62 YR Required Intervention CLOPIDOGREL| ASPIRIN