BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1023545 · Received March 31, 2008

    Report

    Report Number
    2953144-2008-00225
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR INC REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P9600433
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CUFF MISS, POSTERIOR FOOT DETACHMENT. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTEY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE NEEDLE PLUNGER OUT, NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND A STARCLOSE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. INSPECTION OF THE DEVICE BY THE ACCOUNT MANAGER REVEALED THAT THE POSTERIOR FOOT WAS DETACHED AND WAS NOT RETURNED FOR ANALYSIS. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR INC REDWOOD CITY NA 62034-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STARCLOSE