BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1854335 · Received September 30, 2010

    Report

    Report Number
    2953144-2010-02361
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING NEEDLE PLUNGER REMOVAL, THE SUTURE "RUPTURES" (BREAKS) AT THE "JUNCTION (POSTERIOR TIP/POSTERIOR CUFF) BETWEEN THE SUTURE RAIL AND THE LINK." THE SUTURE RUPTURE (BREAK) OCCURS "BEFORE ANY TENSION IS APPLIED ON THE SUTURE AND BEFORE THE QUICK CUT ACTIVATION. THE PROCEDURE COULD BE COMPLETED (HEMOSTASIS WAS ACHIEVED) AS THE RUPTURE OCCURRED AFTER THE SUTURE RAIL PASSED THROUGH THE KNOT." THERE WERE NO REPORTED ADVERSE PT 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