BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER PLUS CATHETER

    MDR report key: 4200271 · Received October 22, 2014

    Report

    Report Number
    2939520-2014-00089
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 25, 2014
    Product Code
    PDU
    PMA / PMN Number
    K101777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRE-DECONTAMINATION VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND IT WAS OBSERVED THAT NO GUIDEWIRE WAS STUCK ON THE PIONEER PLUS DEVICE. THE REPORTED FAILURE CANNOT BE CONFIRMED. WE WERE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR HIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    THE PIONEER PLUS DEVICE BECAME STUCK AND WOULD NOT COME OFF THE WIRE. THE WHOLE SYSTEM WAS REMOVED FROM THE BODY TOGETHER AS A SINGLE UNIT. THE PHYSICIAN DECIDED TO STOP AND ABORT THE PROCEDURE. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674292 PIONEER PLUS CATHETER CATHETER FOR CROSSING TOTAL OCCLUSION PDU PLUS120

    Patients

    Seq Age Sex Outcome Treatment
    1