BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18697935 · Received February 13, 2024

    Report

    Report Number
    2024168-2024-01758
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    28717648013083
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. TWO STERILE/UNUSED DEVICES WITH LOT # 3101542 AND 3102341 WERE RETURNED AND WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    B3, B6, D10: DATES ARE ESTIMATED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS DONE WITH THREE PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IT WAS NOTED AT THE TIME OF DEPLOYMENT THAT ONE OF THE PROGLIDE FOOTPLATES WAS DIFFICULT TO CLOSE. THE TAVR PROCEDURE WAS COMPLETED USING A LARGE-BORE SHEATH. REPORTEDLY, POST PROCEDURE, THE SAME PROGLIDE SUTURE FRAYED AND BROKE DURING KNOT ADVANCEMENT. THE TWO REMAINING PRE-PLACED PROGLIDE SUTURES WERE SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766098 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3101542 28717648013083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLOSURE DEVICE: 2X PROGLIDE