BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE¿

    MDR report key: 22009490 · Received May 13, 2025

    Report

    Report Number
    2024168-2025-04957
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ADDITIONALLY, 64 STERILE/UNUSED DEVICES WITH LOT # 5032541 WERE RETURNED AND 10 WERE SUCCESSFULLY TESTED WITH NO ANOMALIES NOTED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A VENOUS CLOSURE OF A COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE PRIOR TO A WATCHMAN PROCEDURE VIA AN 8F SHEATH. REPORTEDLY, TEN PROGLIDE CUFF MISSES [SUTURE RETRIEVAL ISSUES] WERE NOTICED. THE WATCHMAN PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH A FIGURE OF 8 STITCH. 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
    1241654 PERCLOSE PROGLIDE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12673-03 5032541 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention