BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRANATOR PTA SERRATION BALLOON CATHETER

    MDR report key: 16310846 · Received February 7, 2023

    Report

    Report Number
    16310846
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    September 8, 2022
    Report Date
    February 3, 2023
    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 BALLOON FGS-0492-40120 RUPTURED WHILE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226206 SERRANATOR PTA SERRATION BALLOON CATHETER CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO CAGENT VASCULAR, LLC FGS-0492-40120

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Male