BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 16773257 · Received April 19, 2023

    Report

    Report Number
    1416980-2023-01881
    Event Type
    Injury
    Date Received
    April 19, 2023
    Report Date
    April 19, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    DXZ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 2012-2022. LITERATURE ARTICLE: SUEHYUN PARK, TAEWAN KU, DEOKBI HWANG, WOO-SUNG YUN, HYUNG-KEE KIM, AND SEUNG HUH. ¿OUTCOMES OF ISOLATED ENDARTERECTOMY AND PATCH ANGIOPLASTY OF THE COMMON FEMORAL ARTERY ACCORDING TO CURRENT INCLUSION CRITERIA FOR ENDOVASCULAR TREATMENT¿. VASC SPECIALIST INT. 2022 DEC 27; 38:32. DOI: 10.5758/VSI.220040. THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A STUDY WAS PERFORMED INVOLVING 45 PATIENTS THAT UNDERWENT ISOLATED COMMON FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY (IFEA). VASCU-GUARD WAS USED AS A PATCH ANGIOPLASTY FOLLOWING THE ENDARTERECTOMY PROCEDURE WHERE NECESSARY. TWO PATIENTS EXPERIENCED WOUND INFECTIONS. ONE OF THE PATIENT¿S UNDERWENT DRAINAGE OF THE FEMORAL WOUND AND DELAYED CLOSURE AFTER WOUND DRESSING. TREATMENT FOR THE OTHER PATIENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOMES WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372012 VASCU-GUARD PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention