BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 21349253 · Received February 10, 2025

    Report

    Report Number
    2024168-2025-01485
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 31, 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
    AS
    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. B3: THE DATE OF EVENT HAS BEEN ESTIMATED.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED UNSPECIFIED FAILURE MODE COULD NOT BE VERIFIED AS THE RETURNED DEVICE ANALYSIS INDICATES THE DEVICE WAS SUCCESSFULLY DEPLOYED. PRODUCTION RECORD REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE FOR THIS COMPLAINT WAS NOT PROVIDED. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY WAS NOT PERFORMED AS A SIMILARITY COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED UNSPECIFIED DEVICE ISSUE COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. D4 - LOT # CORRECTION - LOT UPDATED FROM 4053041 TO 4081343.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL CLOSURE WAS ATTEMPTED WITH A PROSTYLE DEVICE RELATIVE TO A PROCEDURE. REPORTEDLY, AN UNSPECIFIED FAILURE OCCURRED. THE METHOD OF HEMOSTASIS WAS NOT PROVIDED. 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
    783698 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4081343 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention