BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRANATOR

    MDR report key: 20757314 · Received November 22, 2024

    Report

    Report Number
    20757314
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 12, 2024
    Manufacturer
    CAGENT VASCULAR, LLC
    Product Code
    PNO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SERRANATOR 5X40MMX150CM BALLOON RUPTURED. BALLOON STILL INTACT. REPORTED TO MANAGEMENT AND SENT BACK TO MANUFACTURING. REPORT SHEET FILLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852861 SERRANATOR CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO CAGENT VASCULAR, LLC FA24040506

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male