BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRANATOR PTA SERRATION BALLOON CATHETER

    MDR report key: 18702108 · Received February 14, 2024

    Report

    Report Number
    18702108
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    November 14, 2023
    Report Date
    February 7, 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

    DURING THE CASE, A BALLOON WAS INFLATED. DURING INFLATION, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED AND WAS STILL INTACT UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70287 SERRANATOR PTA SERRATION BALLOON CATHETER CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO CAGENT VASCULAR, LLC FA23072105

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male