BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3043570 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02108
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    September 14, 2012
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPROPER OR INCORRECT PROCEDURE OR METHOD, PATIENT ANATOMY. PER INSTRUCTIONS FOR USE: WARNINGS: DO NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY OR THE PROFUNDA FEMORIS ARTERY, OR THE BIFURCATION OF THESE VESSELS, SINCE SUCH PUNCTURE SITES MAY RESULT IN A PSEUDOANEURYSM, INTIMAL DISSECTION OR AN ACUTE VESSEL CLOSURE (THROMBOSIS OF SMALL ARTERY LUMEN). IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED IN A MORBIDLY OBESE PATIENT. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WHO ARE MORBIDLY OBESE (BODY MASS INDEX GREATER THAN 35 KG/M). 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.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW, THE USE OF THE "PRECLOSURE" TECHNIQUE FOR ANTEGRADE ASPIRATION THROMBECTOMY WITH LARGE CATHETERS IN ACUTE LIMB ISCHEMIA. THIS STUDY WAS DESIGNED TO ASSESS RETROSPECTIVELY SHORT AND MID-TERM OUTCOMES OF THE USE OF A SUTURE-MEDIATED CLOSURE DEVICE TO CLOSE THE ANTEGRADE ACCESS IN PATIENTS UNDERGOING PERCUTANEOUS ASPIRATION THROMBECTOMY WITH LARGE CATHETERS FOR ACUTE LEG ISCHEMIA. FOR THIS CASE, A (B)(6) MALE UNDERWENT PERCUTANEOUS TREATMENT OF AN ACUTELY THROMBOSED POPLITEAL ANEURYSM WITH STENT-GRAFT PLACEMENT, "ON-TABLE" THROMBOLYSIS, AND PAT. THE SUPERFICIAL FEMORAL ARTERY WAS CHOSE TO ACCESS BECAUSE ANTEGRAD PUNCTURE OF THE COMMON FEMORAL ARTERY WOULD HAVE RESULTED IN A STEEP ANGULATION OF THE DEVICE OR RESPECTIVELY THE INTRODUCER SHEATH. THERE WAS SERIOUS BLEEDING AT THE PUNCTURE SITE AFTER SUTURE-MEDICATED CLOSURE. USING A CROSSOVER TECHNIQUE, STENT-GRAFT INSERTION WAS PERFORMED TO SEAL THE HOLE. ON THE COMPLETION ANGIOGRAM, THE SUPERFICIAL FEMORAL ARTERY ACCESS WAS SEALED. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145096 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SHEATH: 6FR-12FR HEPARIN