BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22013913 · Received May 13, 2025

    Report

    Report Number
    2024168-2025-05006
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 28, 2025
    Report Date
    July 2, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS NOT CONFIRMED AS NOT ALL COMPONENTS WERE RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE REPORTED INFORMATION AND OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT IS LIKELY THAT 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 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. D4: CORRECTED LOT NUMBER FROM 4052041 TO 5031041. D4: CORRECTED EXPIRATION DATE FROM 4/30/2026 TO 2/28/2027. D4: CORRECTED PRIMARY UDI NUMBER FROM ((B)(4). H4: CORRECTED DEVICE MFG DATE FROM 5/20/2024 TO 3/10/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WITH FIVE PROSTYLE DEVICES, THE SUTURE WAS NOT PRESENT WHEN THE PLUNGER WAS REMOVED. THE PHYSICIAN DECIDED TO NOT PRE-PLACE ANY MORE DEVICES. THE SHEATH WAS UPSIZED TO 13F, AND THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH A NON-ABBOTT DEVICE AND MANUAL COMPRESSION. 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
    1241928 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5031041 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention