BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3852331 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03625
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    March 1, 2013
    Report Date
    April 4, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED DATE OF OCCURRENCE. (B)(4) - INCORRECT ANATOMY. THIS CODE IS USED TO ADDRESS THE USE OF THE PROGLIDE DEVICE IN THE FEMORAL VEIN. PER THE INSTRUCTIONS FOR USE- INDICATIONS: THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOT THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. THE DEVICES ARE NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ARTICLE: NICOLAS A. GEIS, MD; SVEN T. PLEGER, MD; EMMANUEL CHORIANOPOULOS, MD; OLIVER J. MULLER, MD; HUGO A. KATUS, MD; RAFFI BEKEREDJIAN, MD (EUROINTERVENTION 2014): FEASIBILITY AND CLINICAL BENEFIT OF A SUTURE-MEDIATED CLOSURE DEVICE FOR FEMORAL VEIN ACCESS AFTER PERCUTANEOUS EDGE-TO- EDGE MITRAL VALVE REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING PROGLIDE DEVICES THAT MAY BE RELATED TO THE FOLLOWING: DEVICE DEPLOYMENT FAILURE, KNOT ADVANCEMENT ISSUE, HEMATOMA, HEMORRHAGE, BLOOD TRANSFUSION, USE OF A FIGURE 8 SUTURE, MANUAL COMPRESSION AND PRESSURE BANDAGE. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "FEASIBILITY AND CLINICAL BENEFIT OF A SUTURE-MEDIATED CLOSURE DEVICE FOR FEMORAL VEIN ACCESS AFTER PERCUTANEOUS EDGE-TO- EDGE MITRAL VALVE REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329346 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 7F, 24F