BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21607248 · Received March 14, 2025

    Report

    Report Number
    2024168-2025-02672
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 4, 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
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE AND THE REPORTED SUTURE DETACHMENT WAS OBSERVED AS A LINK DETACHMENT. A NEEDLE TO CUFF MISS WAS ALSO OBSERVED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES 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 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: G3 - DATE RECEIVED BY MFG UPDATED FROM 2/18/25 TO 3/11/25. ADDITIONAL INFORMATION RECEIVED: D4: PART #/LOT # UPDATED FROM UNK TO 12773-02/4092342.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN WAS ATTEMPTED WITH A PROSTYLE DEVICE USING A LARGE-BORE SHEATH AFTER AN ELECTROPHYSIOLOGY PROCEDURE. REPORTEDLY, AFTER THE PLUNGER WAS REMOVED, THE SUTURE BROKE JUST BEFORE IT COULD BE CUT WITH THE QUICK CUT. A NEW PROSTYLE DEVICE 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
    1148227 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4092342 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention