BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 23010075 · Received September 9, 2025

    Report

    Report Number
    2024168-2025-09588
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE MATERIAL SEPARATION WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, SUTURE/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: CORRECTED LOT # FROM 5071941. TO 5070941. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 0

    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 THIS WAS A VENOTOMY CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A SMALL-BORE SHEATH. REPORTEDLY, A SUTURE BREAK WAS OBSERVED AFTER REMOVAL OF THE PLUNGER. A NEW PROGLIDE DEVICE WAS USED TO 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
    2839153 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 5070941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention