BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 24268155 · Received February 5, 2026

    Report

    Report Number
    2024168-2026-00506
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 4, 2026
    Report Date
    March 20, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    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. B3: DATE OF EVENT: ESTIMATED. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY WITH THE LEVER/FOOT WAS NOT CONFIRMED AS THE FOOT DEPLOYMENT AND RETRACTION WERE VERIFIED VIA MANUALLY OPENING AND CLOSING THE LEVER WITH NO ANOMALIES NOTED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED DEVICE, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED. FACTORS THAT CONTRIBUTE TO THE INABILITY TO RETRACT THE FOOT, INCLUDE, BUT NOT LIMITED TO TISSUE, SUTURE CAUGHT IN FOOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: B5 - DESCRIBE EVENT OR PROBLEM: UPDATED. D4 - LOT #: UPDATED FROM UNKNOWN TO 5091741. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE FOOTPLATE WAS ALREADY OUT" WITH A PROGLIDE DEVICE RELATIVE TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE RECEIVED FROM THE HOSPITAL AFTER THE PROCEDURE HAS BLOOD ON IT. THE NEEDLES OF THE DEVICE ARE ALSO REMOVED WHICH INDICATES THE DEVICE WAS USED AND THE PROBLEM WAS THAT THE FOOTPLATE WAS OFFSET. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, IT WAS NOTED THAT THE DEVICE WAS A PROSTYLE DEVICE AND NOT A PROGLIDE AS WAS ORIGINALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327659 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5091741 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown