BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2781493 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06404
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 18, 2012
    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). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, 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. REPORTEDLY THE COMMON FEMORAL ARTERY WAS MODERATELY CALCIFIED. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICES, ARE BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN A MODERATELY CALCIFIED COMMON FEMORAL ARTERY USING PERCLOSE PROGLIDE DEVICES. REPORTEDLY, THE DEVICES WERE INSERTED INTO THE VESSEL THROUGH A 6-FRENCH SIZED ACCESS SITE. DURING EACH ATTEMPT TO DEPLOY THE SUTURES OF THREE PROGLIDES DEVICES, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED OF EACH DEVICE, NO SUTURE WAS PRESENT ON THE NEEDLES. TWO ADDITIONAL PROGLIDE DEVICES WERE SEQUENTIALLY DEPLOYED 60-DEGREES OPPOSITE IN ORIENTATION AND SET TO THE SIDE. THE ACCESS SITE WAS DILATED TO 18-FRENCH TO MATCH THE OUTER DIAMETER OF THE DELIVERY CATHETER. AFTER CONCLUSION OF THE TAVI PROCEDURE, THE KNOTS FROM THE TWO 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 IS REPORTEDLY 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 6-FRENCH