BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23645717 · Received November 25, 2025

    Report

    Report Number
    2024168-2025-11752
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 5, 2025
    Report Date
    April 1, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS OBSERVED AS A NEEDLE TO CUFF MISS. 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. THE REPORTED DIFFICULTIES 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. BASED ON THE 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 5081842 REMOVED. CORRECTION: H6 - MEDICAL DEVICE PROBLEM CODE 2921 REMOVED.

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

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THIS WAS A MULTI-ACCESS VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL ATRIAL FIBRILLATION (AF) AND VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. THE FOOT WOULD NOT CLOSE FOR ALL THREE PROSTYLE DEVICES WAS MISREPORTED. INSTEAD, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED WITH ALL THREE DEVICES. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO AN 8FR SHEATH AND THE AF AND VT PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNKNOWN VESSEL USING THREE PROSTYLE DEVICES RELATED TO AN UNKNOWN PROCEDURE. REPORTEDLY, THE FOOT WOULD NOT CLOSE FOR ALL THREE DEVICES. AN UNKNOWN METHOD WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED 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
    195048 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5090243 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown