BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1920257 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03185
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE #2 PERCLOSE PROGLIDE 12673-03/UNK IS BEING FILED UNDER A SEPARATE MEDWATCH MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING, IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DIFFICULTY WAS ENCOUNTERED WITH THE INSERTION OF THE PROCEDURAL SHEATH. THE SHEATH WAS REPLACED. THE PROGLIDE DEVICE WAS INSERTED AND A CUFF MISS OCCURRED. ANOTHER PROGLIDE DEVICE WAS USED AND AFTER NEEDLE DEPLOYMENT IT WAS OBSERVED THAT THE SUTURES CAPTURED PLAQUE. AN ANGIOGRAM WAS TAKEN AFTER THE PROGLIDE DEVICE WAS REMOVED AND AN INTIMAL DISSECTION WAS NOTICED. THE DISSECTION WAS NOT FLOW LIMITING. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention #2 PERCLOSE PROGLIDE 12673-03/UNK