BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2894986 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00018
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. 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 A TRANSCATHETER AORTIC VALVE REPLACEMENT (TVAR) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED OF THE RIGHT COMMON FEMORAL ARTERY THROUGH A 5-FRENCH SIZED ACCESS SITE USING TWO PERCLOSE PROGLIDE DEVICES. REPORTEDLY, THE PROGLIDE SUTURES WERE SEQUENTIALLY DEPLOYED. THE ACCESS SITE WAS DILATED FOR THE TVAR PROCEDURE TO 24-FRENCH. AFTER CONCLUSION OF THE TVAR PROCEDURE, THE KNOTS FROM THE TWO PROGLIDE DEVICES WERE SEQUENTIALLY ADVANCED AND TIGHTENED. INITIALLY THERE WAS NO BLEEDING BUT WHILE STILL IN THE CATH LAB THE ACCESS SITE STARTED TO BLEED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN DID NOT FEEL THERE WAS ANY ISSUE WITH THE DEVICE AND FELT THE SUTURE WAS PROPERLY PLACED. THE PHYSICIAN SURMISED THE PATIENT MAY HAVE MOVED OR POSSIBLY HE DID NOT PROPERLY CINCH THE KNOT (TO THE ARTERIAL SURFACE). THE PHYSICIAN WAS REPORTED TO BE 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
    2176 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21017J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATHS: 5-FRENCH & 24-FRENCH. HEPARIN