BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4243472 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07341
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: CORRECTION - CHANGED FROM 40811K1 TO 40625K1. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED NEEDLE-TO-CUFF MISS 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, THE CUSTOMER RETURNED ONE UNUSED STERILE PROGLIDE DEVICE (PART NUMBER 12673-03, LOT NUMBER 40811K1) FOR EVALUATION. THE DEVICE WAS DEPLOYED AND PERFORMED ACCORDING TO SPECIFICATIONS. BASED ON THE VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED AGE - REPORTEDLY THE PATIENT WAS APPROXIMATELY (B)(6) YEARS OLD. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. CALCIFICATION WAS REPORTEDLY PRESENT AT THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE. THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATE UNDER THE SPECIAL PATIENT POPULATIONS SECTION THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE OTHER PERCLOSE PROGLIDE DEVICES WERE FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS ENDOVASCULAR AORTIC ANEURYSM REPAIR (PEVAR) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN THE LEFT COMMON FEMORAL ARTERY (LCFA) AND IN A CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) THROUGH 7-FRENCH SIZED ACCESS SITES. REPORTEDLY, DURING SUTURE PLACEMENT AT 12 O'CLOCK POSITION IN THE LCFA, A NEEDLE-TO-CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND THE SUTURES FROM TWO ADDITIONAL PROGLIDES, ONE AT THE 12 O'CLOCK POSITION AND ONE AT THE DEVICE 10 O'CLOCK DEVICE, WERE PREPLACED AT THE ACCESS SITE AND SET TO THE SIDE. REPORTEDLY, DURING SUTURE PLACEMENT AT THE RCFA ACCESS SITE, THE INITIAL SIX PROGLIDES INCURRED A NEEDLE-TO-CUFF MISS. THE SUTURES OF TWO ADDITIONAL PROGLIDE DEVICES WERE DEPLOYED AND SET TO THE SIDE. THE LCFA ACCESS SITE WAS UPSIZED FROM 7-FRENCH TO 12-FRENCH AND THE RCFA ACCESS SITE WAS UPSIZED FROM 7-FRENCH TO 14-FRENCH. AFTER THE PEVAR PROCEDURE, THE SUTURES AT BOTH ACCESS SITES WERE USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTEDLY TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE AND IN-TRAINING IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726622 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40625K1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATHS 7F(TWO), 12F, 14F, HEPARIN