BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1892699 · Received November 3, 2010

    Report

    Report Number
    2953144-2010-02710
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PT SELECTION (HEAVILY CALCIFIED ARTERY). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE ANALYSIS, A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. HOWEVER, THE DEVICE WAS USED IN A HEAVILY CALCIFIED ARTERY AND AS PER THE INSTRUCTIONS FOR USE, IT STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE HAS NOT BEEN ESTABLISHED IN THE FOLLOWING POPULATIONS: PTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. A REVIEW OF THE DEVICE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING KNOT ADVANCEMENT, THE KNOT WOULDN'T ADVANCE AS THE VESSEL WAS HEAVILY CALCIFIED. A NON-ABBOTT DEVICE AND MANUAL COMPRESSION WERE APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT 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 Required Intervention