BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1772411 · Received July 23, 2010

    Report

    Report Number
    2953144-2010-01454
    Event Type
    Injury
    Date Received
    July 23, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION OF THE RETURNED DEVICE FOUND ONLY THE PLUNGER WITH LINK AND CUFFS WERE RETURNED FOR EVALUATION. THE ANTERIOR CUFF WAS ATTACHED TO THE NEEDLE TIP WITH THE LINK INTACT. THE POSTERIOR CUFF WAS NOT ATTACHED AND TWO OF ITS CUFF TABS HAD BEEN FLATTENED AND ONE WAS BENT DISTALLY. THE SINGLE BENT TAB INDICATES THE CUFF WAS PARTIALLY CAPTURED AND THAT THE NEEDLE MAY HAVE BEEN DEFLECTED STRIKING THE CUFF AT ANGLE THAT PREVENTED COMPLETE CAPTURE, RESULTING IN THE SUTURE NOT BEING HARVESTED; HOWEVER, BECAUSE OF THE LIMITED COMPONENTS, THIS CANNOT BE CONCLUSIVELY CONFIRMED. NO MANUFACTURE OR QUALITY ISSUES WERE DETECTED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: UNKNOWN. TIME OF DEVICE ISSUE: UNKNOWN. ADVERSE EVENT: UNKNOWN. A PROGLIDE DEVICE WAS RETURNED TO ABBOTT VASCULAR. ALTHOUGH NO DEVICE MALFUNCTION OR COMPLAINT ASSOCIATED WITH THIS DEVICE COULD BE CONFIRMED, PER THE DEVICE ANALYSIS THE POSTERIOR CUFF WAS FOUND NOT ATTACHED AND TWO TABS HAD BEEN FLATTENED AND ONE WAS BENT DISTALLY. THE SINGLE BENT TAB INDICATES THE CUFF WAS PARTIALLY CAPTURED AND ALTHOUGH IT COULD NOT BE CONFIRMED WITH THE LIMITED RETURN OF COMPONENTS, THE NEEDLE MAY HAVE BEEN DEFLECTED STRIKING THE CUFF AT AN ANGLE THAT PREVENTED COMPLETE CAPTURE, RESULTING IN THE SUTURE NOT BEING HARVESTED. IT WAS NOT SPECIFIED HOW HEMOSTASIS WAS ACHIEVED. 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 - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1