BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4090216 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05924
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 2014
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE OBSERVED ANTERIOR CUFF REMAINING IN THE FOOT POCKET INDICATES AN ANTERIOR CUFF MISS LIKELY OCCURRED. THE CUFF MISS AND LINK DETACHMENT LIKELY RESULTED IN FAILURE TO RETRIEVE THE SUTURE, APPEARING AS AN ISSUE WITH THE SUTURE NOT CAPTURING THE VESSEL WALL; THEREFORE, THE REPORTED SUTURE NOT CAPTURING THE VESSEL WALL IS CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH A PROGLIDE DEVICE WAS ATTEMPTED IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE NEEDLES IT WAS NOTED THAT THE SUTURE DID NOT CAPTURE THE VESSEL WALL. THE PROGLIDE WAS REMOVED AND AN ADDITIONAL PROGLIDE DEVICE WAS USED AND PLACEMENT OF THE SUTURE WAS SUCCESSFUL USING THE PRECLOSE TECHNIQUE. THE INITIAL PROCEDURAL SHEATH SIZE WAS UPSIZED TO WAS NOT SPECIFIED; HOWEVER, THE SHEATH WAS REPORTEDLY UPSIZED TO A 12F SHEATH. THE EVAR PROCEDURE WAS SUCCESSFULLY COMPLETED. HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED PROGLIDE SUTURES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568614 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40530K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 12F