BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21635482 · Received March 18, 2025

    Report

    Report Number
    2024168-2025-02832
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    November 1, 2024
    Report Date
    August 28, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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 DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED ANALYSIS. THE REPORTED MALPOSITION/FAILURE TO DEPLOY THE SUTURE WAS CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR FRIABLE VESSEL DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTION: D4: LOT NUMBER UPDATED FROM 4020741 TO 4021341. CORRECTION: H6 - ADVERSE EVENT PROBLEM 1142 REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL CLOSURE WAS ATTEMPTED WITH 3 PROSTYLE DEVICES RELATIVE TO A PROCEDURE. REPORTEDLY, DURING PLUNGER REMOVAL, THE SUTURE THREADS APPEARED LOOSE IN THE OPERATOR'S HAND AND THE STITCH [SUTURE/ KNOT] WAS MADE OUTSIDE THE PATIENT. A NEW [UNSPECIFIED] 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, PER THE DEVICE ANALYSIS ONE OF THE PROSTYLE DEVICES (4021341) APPEARED TO BE A SUTURE MALPOSITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373528 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4021341 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention