BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 22185107 · Received June 11, 2025

    Report

    Report Number
    2024168-2025-06012
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED BLOCKED MARKER LUMEN WAS NOT CONFIRMED. 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 APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS LIKELY THAT ANATOMICAL CONDITIONS OR UNDER INSERTION OF THE DEVICE CONTRIBUTED TO THE REPORTED NO PULSATILE FLOW FROM THE MARKER LUMEN. THE TREATMENT APPEARS TO BE RELATED TO THE 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. CORRECTIONS: D4 - LOT #: UPDATED FROM 4101841 TO 4121941. D4 - EXPIRATION DATE: UPDATED FROM 9/30/2026 TO 11/30/2026. D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(4). H4 - DEVICE MFG DATE: UPDATED FROM 10/19/2024 TO 12/19/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN ENDOVASCULAR THROMBECTOMY (EVT) INTERVENTIONAL PROCEDURE USING AN 8F SHEATH. REPORTEDLY, THERE WAS NO BLOOD FLOW COMING FROM THE MARKER LUMEN WHEN THE DEVICE WAS POSITIONED IN THE ARTERY. THE DEVICE HAD BEEN FLUSHED SUCCESSFULLY PRIOR TO USE. ANOTHER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN ENDOVASCULAR THROMBECTOMY (EVT) INTERVENTIONAL PROCEDURE USING AN 8F SHEATH. REPORTEDLY, THERE WAS NO BLOOD FLOW COMING FROM THE MARKER LUMEN WHEN THE DEVICE WAS POSITIONED IN THE ARTERY. THE DEVICE HAD BEEN FLUSHED SUCCESSFULLY PRIOR TO USE. ANOTHER 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
    93636 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4121941 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention