BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22118400 · Received May 30, 2025

    Report

    Report Number
    2024168-2025-05541
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE MAL POSITION OF THE DEVICE WAS CONFIRMED AS A FAILURE TO CYCLE OF THE ANTERIOR NEEDLE. (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. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE AND SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, AN ANTERIOR NEEDLE TO CUFF MISS OCCURRED. 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 5032341 TO 5040141. D4: CORRECTED EXPIRATION DATE FROM 2/28/2027 TO 3/31/2027. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4). H4: CORRECTED DEVICE MFG DATE FROM 3/23/2025 TO 4/1/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING A PROSTYLE DEVICE AFTER A CARDIAC ABLATION PROCEDURE WITH A 7F SHEATH. REPORTEDLY, AFTER PERFORMING STEP 4, THE SUTURE WAS ONLY ATTACHED TO THE FOOT PLATE AND NOT LEFT BEHIND. A NEW PROSTYLE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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
    735928 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 5040141 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention