BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1790274 · Received August 6, 2010

    Report

    Report Number
    2953144-2010-01566
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO DEPLOY PLUNGER. TIME OF DEVICE ISSUE: AFTER VESSEL CLOSURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE "COLLAR DID NOT FULLY ENGAGE WITH THE BODY." SUTURE DEPLOYMENT WAS COMPLETED AND THE SUTURE ACHIEVED HEMOSTASIS. 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 - REDWOOD CITY NA 82002-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR