BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 8453884 · Received March 26, 2019

    Report

    Report Number
    2024168-2019-02333
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 22, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 8202542 TO UNK. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. REPORTEDLY, THE SUTURES WERE DIFFICULT TO REMOVE FROM THE GUIDE OF THE PROGLIDE DEVICE. THE SUTURES WERE CUT AND THE DEVICE WAS REMOVED. THE SUTURES OF ANOTHER PROGLIDE DEVICE WERE SUCCESSFULLY REPLACED. THE SHEATH WAS UPSIZED TO 16F AND THE TAVR PROCEDURE WAS COMPLETED. THE SUCCESSFULLY REPLACED SUTURES WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244777 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 8202542

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6FHEPARIN