BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3962060 · Received July 28, 2014

    Report

    Report Number
    2024168-2014-04831
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER SEPARATE A MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED EVENT OF NEEDLE TO CUFF MISS/SUTURE RETRIEVAL ISSUE WAS CONFIRMED. 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. 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 PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, THE SUTURES OF PROGLIDE DEVICES WERE ATTEMPTED TO BE PLACED BILATERALLY IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) AND THE LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PRECLOSE TECHNIQUE. THERE WAS NO ISSUE WITH THE PRECLOSE PROCEDURE IN THE RCFA. REPORTEDLY, TWO CUFF MISSES OCCURRED IN THE LCFA DURING THE ATTEMPTED PRECLOSE TECHNIQUE. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY PLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 8F. THE SHEATH WAS UPSIZED TO 20F FOR THE AAA PROCEDURE. AFTER THE AAA PROCEDURE WAS COMPLETED, THE SUCCESSFULLY PREPLACED SUTURES ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437511 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40122K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FR, 20FR, HEPARIN