BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2011064 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01527
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. USE IN MORBIDLY OBESE PATIENT. 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 PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED A RETROPERITONEAL BLEED. THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) OF 1.9. ANTICOAGULANT THERAPY WAS STOPPED AND THE PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS, VITAMIN K, AND FLUIDS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 69 YR Required Intervention HEPARIN