BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1962189 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00356
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 30, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING USING A PROGLIDE DEVICE ACHIEVED ARTERIAL CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, TWO DAYS POST PROCEDURE, (B)(6) 2010 THE PATIENT COMPLAINED OF PAIN IN THE LEG. (B)(6) 2010, THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM AND IT WAS FOUND THAT THERE WAS A NARROWING AT THE CLOSURE SITE. THE PATIENT RETURNED 1/13/2011, SURGERY WAS PREFORMED AND NO SUTURES WERE FOUND. THE ARTERY WAS DISEASED AND AN ENDARECTOMY WAS PERFORMED SUCCESSFULLY. THE PATIENT WAS RELEASED TO GO HOME THE FOLLOWING DAY, (B)(6) 2011. THERE WERE NO ADVERSE PATIENT SEQUELAE REPORTED. THOUGH REQUESTED, 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 SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R