BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3041305 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02078
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. IT IS INDICATED THAT THE DEVICES ARE NOT RETURNING FOR EVALUATION. THIS INCIDENT REPORTED ONLY PATIENT EFFECTS WITH NO ALLEGATION OF A DEVICE ISSUE AND, AS SUCH, IS NOT ON ITS OWN AN INDICATION OF A PRODUCT DEFICIENCY. 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

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY (CFA) WAS ACHIEVED USING A PROGLIDE DEVICE AFTER A HEART CATHETERIZATION PROCEDURE AND THE PATIENT WAS SENT HOME. APPROXIMATELY 6 DAYS LATER, THE PATIENT CAME BACK TO THE E.R. (EMERGENCY ROOM) WITH A COLD LEG. THE CFA WAS EXPLORED AND IT WAS FOUND OCCLUDED. IT SEEMS THAT DURING THE PROCEDURE A FLAP DEVELOPED IN THE CFA AND THROUGH OUT THE DAYS THROMBOSED CAUSING THE OCCLUSION. THE CFA WAS BALLOONED AND STENTED TO TREAT THE OCCLUSION AND THE ACCESS SITE WAS SURGICALLY CLOSED. THE PHYSICIAN IS NOT CERTAIN OF WHAT CAUSED THE FLAP THAT RESULTED IN THE VESSEL OCCLUSION. 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
    143245 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R SHEATH: 6 FR.