BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2936094 · Received January 30, 2013

    Report

    Report Number
    2024168-2013-00498
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXPERIENCE OF DIFFICULT TO INSERT THE GUIDE WIRE WAS CONFIRMED. DURING TESTING, A STANDARD 0.038 INCH PROXY GUIDE WIRE WAS INSERTED INTO THE GUIDE WIRE EXIT PORT USING THE J-TIP. RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL END OF THE ANGLE-CUT SINGLE LUMEN INSERT, WHICH IS INSIDE THE SHEATH. THE SHEATH WAS DISSECTED AT THE AREA, AND A GAP WAS FOUND BETWEEN THE SINGLE LUMEN INSERT (ANGLE-CUT) AND OVER-MOLDED MATERIAL AND THE GAP WAS MEASURED APPROXIMATELY 0.1970 INCHES. A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS. BASED ON AN EXPANDED INVESTIGATION THERE IS A POSSIBLE PRODUCT ISSUE RELATED TO THE DIFFICULT TO INSERT GUIDE WIRE THROUGH THE GUIDE WIRE EXIT PORT. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE ARE ONGOING AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED. IT WAS REPORTED THAT A FEMORAL ANGIOGRAM WAS NOT PERFORMED. THE PROGLIDE INSTRUCTIONS FOR USE STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. REPORTED DEVICE CODE 2017- FAILURE TO FOLLOW IFU STEPS: FAILURE TO PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED IN THE COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A PERCUTANEOUS ENDOVASCULAR AORTIC ANEURYSM REPAIR INTERVENTIONAL PROCEDURE. A FEMORAL ANGIOGRAM WAS NOT PERFORMED. REPORTEDLY, TWO PROGLIDE DEVICES HAD THE SAME PROBLEM, AFTER PLACING THE SUTURES THE GUIDE WIRE COULD NOT BE REINSERTED INTO THE PROGLIDE DEVICES. TWO DIFFERENT WIRES WERE USED BEFORE A GUIDE WIRE WAS REINSERTED. THE SUTURES WERE REMOVED. TWO ADDITIONAL PROGLIDE DEVICES WERE USED FOR SUCCESSFUL SUTURE PLACEMENT AND THESE SUTURES WERE USED TO ACHIEVE HEMOSTASIS AFTER THE INTERVENTIONAL PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41420 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21002J1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SHEATHS: 7F, 8F