BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1895240 · Received November 8, 2010

    Report

    Report Number
    2953144-2010-02750
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 15, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PATIENT SELECTION - HEAVILY CALCIFIED ARTERY, (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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 A HEAVILY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE, AND A SECOND PROGLIDE DEVICE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT 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 930026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention