BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20157548 · Received September 6, 2024

    Report

    Report Number
    2024168-2024-10498
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 4, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648235184
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. B3 - DATE OF EVENT: ESTIMATED.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED POUCH. THE DEVICE WAS NOT RETURNED. REVIEW OF THE PRODUCTION RECORDS AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE 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. WITHOUT THE SPECIFIED FAILURE MODE A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE TREATMENT APPEARS TO BE RELATED 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. ADDITIONALLY, 5 STERILE DEVICES WERE RECEIVED: ON THE POUCH LABEL: PERCLOSE PROSTYLE, PART# 12773-03 AND LOT# 4051641. ON THE DEVICE: LOT# 4051641. ALSO, THEY RETURNED 5 POUCHES WITH SAME PART, LOT# BUT NO DEVICES WERE RETURNED. ANALYSIS WAS PERFORMED PER THE RETURNED GOODS HANDLING PROCEDURE AND VESSEL CLOSURE ANALYSIS AND PER THE TEST PLAN. VISUAL: 5 OF THE 5 RETURNED DEVICES WERE INSPECTED PER THE TEST PLAN. THERE WAS NO DAMAGE NOTED TO THE STERILE/UNUSED DEVICES. FUNCTIONAL: ALL SAMPLES WERE SUCCESSFULLY TESTED PER THE TEST PLAN. THERE WERE NO ANOMALIES NOTED.

    Description of Event or Problem · 0

    THIS WAS REPORTED AS A CLOSURE USING 10 PROSTYLE DEVICES RELATIVE TO AN ENDOGRAFT PROCEDURE. REPORTEDLY, THE DEVICES DID NOT WORK. 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
    1912809 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 4051641 08717648235184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention