BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16575664 · Received March 20, 2023

    Report

    Report Number
    2024168-2023-02885
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    February 24, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICE WITH REPORTED ISSUE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS OBSERVED AS A LINK BREAK. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR LINK PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. D4 - LOT # UPDATED FROM 2111541 TO: 2111441.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN VENOUS CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED WITH A PROGLIDE DEVICE AFTER AN ELECTROPHYSIOLOGY INTERVENTIONAL PROCEDURE USING A SMALL-BORE SHEATH. REPORTEDLY, UPON PULL BACK, THERE WERE NO SUTURES PRESENT. A SECOND DEVICE WAS USED AND THE SAME FAILURE OCCURRED. A THIRD NEW PROGLIDE DEVICE WAS USED TO SUCCESSFULLY ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA 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
    823929 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2111441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention