BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2210930 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05725
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4) - INDICATION FOR USE (NOT USED IN THE COMMON FEMORAL ARTERY). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW WILL NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE PROGLIDE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE CATHETERIZATION PROCEDURES USING 5F TO 8F SHEATHS.

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, A SPECIFIC DEVICE FAILURE WAS NOT REPORTED. AN ANGIOGRAM REVEALED THAT THE PUNCTURE SITE WAS A HIGH STICK, WHICH WAS REPORTED TO HAVE BEEN DONE AT THE RIGHT EXTERNAL ILIAC ARTERY, RATHER THAN PUNCTURING THE RIGHT COMMON FEMORAL ARTERY. THE PROGLIDE SUTURE-MEDIATED CLOSURE (SMC) SYSTEM INSTRUCTIONS FOR USE (IFU) STATES TO NOT USE THE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS. THEREFORE, DEVIATION FROM THE IFU (LOCATION OF THE STICK) IS LIKELY THE CAUSE FOR THE RESULTING ARTERIAL OCCLUSION THAT REQUIRED SURGICAL INTERVENTION TO RESTORE BLOOD FLOW. A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT IDENTIFIED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE REVIEW OF THE EVENT INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS PERFORMED USING A 6FR SHEATH PRIOR TO A CAROTID STENTING PROCEDURE. IT WAS OBSERVED THAT THE PUNCTURE WAS A HIGH STICK, IT HAD BEEN DONE AT THE RIGHT EXTERNAL ILIAC ARTERY, RATHER THAN PUNCTURING THE RIGHT COMMON FEMORAL ARTERY (RCFA). THE INDEX PROCEDURE WAS COMPLETED AND VESSEL CLOSURE ATTEMPTED. ALL THE DEPLOYMENT STEPS WERE COMPLETED UNEVENTFULLY DURING VESSEL CLOSURE AND HEMOSTASIS ACHIEVED. LATER THAT EVENING, THE PATIENT DEVELOPED A COLD LEG. THE SAME GROIN WAS ACCESSED AND IT WAS OBSERVED THAT THE SUTURES HAD CAUGHT THE ARTERIAL BACK WALL STITCHING THE VESSEL TOGETHER, WHICH WAS DESCRIBED AS OCCLUDED. THE RIGHT EXTERNAL ILIAC WAS SURGICALLY OPENED AND BLOOD FLOW RESTORED. THIS EVENT DID NOT PROLONG THE PATIENT'S HOSPITALIZATION, SINCE IT WAS PLANNED TO KEEP THE PATIENT OVERNIGHT DUE TO THE INDEX PROCEDURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 60 YR Required Intervention SHEATH: 6 FR. OTHER: HEPARIN.