BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1083439 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01246
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: OCCLUSION/LOW PULSES. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A TRAINED PHYSICIAN ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING THE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. THE PT WAS REPORTED AS FINE; HOWEVER, AFTER THE PROCEDURE IN 2008, THE PULSES WERE LOW AND DIFFICULT TO FIND. ABOUT 2 DAYS LATER, THE PT HAD A COVERED STENT IMPLANTED AND THE PT'S PULSES WERE RESTORED. THE PT WAS RELEASED FROM THE HOSPITAL IN THE NEXT DAY. THERE WAS NO OTHER REPORTED PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 Hospitalization| R