BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2873951 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07933
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. THE PLUNGER, CUFFS,LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED WITH THE DEVICE, WHICH WOULD HAVE AIDED IN THE INVESTIGATION. BASED ON 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    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 INFORMATION. THE OTHER THREE PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUFF MISSES OCCURRED DURING ATTEMPTED SUTURE PLACEMENT IN BOTH MODERATELY CALCIFIED COMMON FEMORAL ARTERIES USING THE PRECLOSE TECHNIQUE PRIOR TO AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. A SECOND PROGLIDE DEVICE WAS USED ON BOTH SIDES WITH THE SAME RESULTS. ANOTHER PROGLIDE DEVICE WAS USED ON EACH SIDE FOR SUCCESSFUL SUTURE PLACEMENT. THE AAA PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE SUCCESSFULLY DEPLOYED PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20928J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 6F, IN EXCESS OF 14FHEPARIN