BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3803200 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02976
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 17, 2014
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CUFF MISS WAS CONFIRMED. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS OR EXCEPTIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 WAS ATTEMPTED IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM PROCEDURE (AAA). REPORTEDLY, A CUFF MISS OCCURRED. A SECOND AND THIRD PROGLIDE DEVICE WERE USED FOR SUCCESSFUL SUTURE PLACEMENT. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURES OF THE TWO PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281737 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40130K1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention HEPARIN