BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7215578 · Received January 24, 2018

    Report

    Report Number
    2024168-2018-00555
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    January 10, 2018
    Report Date
    February 8, 2018
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT #CHANGED FROM 7111341 TO 7113042. EVALUATION SUMMARY: VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED CUFF MISS COULD NOT BE TESTED DUE TO DEVICE COMPONENTS NOT BEING RETURNED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO USER TECHNIQUE AND/OR AN INTERACTION WITH PATIENT ANATOMY AND THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH A PROGLIDE DEVICE WAS ATTEMPTED IN THE CALCIFIED RIGHT COMMON FEMORAL ARTERY VIA 6FR SHEATH USING THE PRECLOSE TECHNIQUE PRIOR TO A PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (PEVAR) PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. TWO ADDITIONAL PROGLIDE DEVICES WERE USED FOR SUCCESSFUL SUTURE PLACEMENT USING THE PRECLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 18FR AND THE PEVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES OF THE PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE AND BEING ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59872 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 7113042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR HEPARIN