BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3051371 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02185
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EXPERIENCE 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 NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED OF THE LEFT AND RIGHT COMMON FEMORAL ARTERIES (CFA) USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING PRE-CLOSE PLACEMENT OF THE SUTURE THROUGH A 6-FRENCH SIZED ACCESS SITE IN THE LEFT CFA, WHEN THE NEEDLE PLUNGER OF THE INITIAL DEVICE WAS REMOVED NO SUTURE WAS PRESENT. THE DEVICE WAS REMOVED AND THE SUTURES OF TWO PROGLIDE DEVICES WERE DEPLOYED AND CLAMPED TO THE SIDE. REPORTEDLY DURING PRE-CLOSE PLACEMENT OF THE SUTURE THROUGH A 6-FRENCH SIZED ACCESS SITE IN THE RIGHT CFA, THE SUTURE FAILED TO CAPTURE. THE DEVICE WAS REMOVED AND THE SUTURES FROM TWO ADDITIONAL PROGLIDE DEVICES WERE DEPLOYED AND CLAMPED TO THE SIDE. BOTH THE LEFT CFA AND RIGHT CFA ACCESS SITES WERE UPSIZED TO 14-FRENCH. AFTER CONCLUSION OF THE AAA REPAIR PROCEDURE, THE KNOTS FROM THE PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE IN- TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153116 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21009J1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SHEATHS: (2) 6-FRENCH, (2) 14-FRENCH