BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21575279 · Received March 11, 2025

    Report

    Report Number
    2024168-2025-02501
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 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
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MECHANICAL JAM OF THE PLUNGER COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. HOWEVER, THE RETURNED PLUNGER WAS INSERTED IN THE DEVICE TO DEPLOY THE NEEDLES. THE RETURNED PLUNGER WAS FULLY DEPLOYED AND REMOVED WITH NO RESISTANCE. 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. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED MECHANICAL JAM OF THE PLUNGER COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO A MECHANICAL JAM (PLUNGER DEPLOYMENT ISSUE) INCLUDE, BUT ARE NOT LIMITED TO, NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH PATIENT ANATOMY (HUMAN TISSUE, CALCIFIED FEMORAL VESSEL, ETC.) OR FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED: D4 - LOT # UPDATED FROM UNK TO 4110442.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF AN ARTERY USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRICLIP PROCEDURE. REPORTEDLY, A PROSTYLE PLUNGER COULD NOT BE PUSHED IN STEP 2. IT WAS BLOCKED. THE SUTURES OF TWO NEW PROSTYLE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE TRICLIP PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. 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
    367963 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4110442 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention