BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT

    MDR report key: 4110994 · Received September 23, 2014

    Report

    Report Number
    2953200-2014-01897
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: MANUFACTURING RELATED.

    Description of Event or Problem · 1

    A RELIANT BALLOON WAS SELECTED AS AN ACCESSORY DEVICE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A RELIANT BALLOON WAS SELECTED FOR USE FOR TOUCH UP AFTER ANOTHER MANUFACTURER¿S DEVICE WAS IMPLANTED HOWEVER, THE PHYSICIAN WAS UNABLE INFLATE THE DEVICE. THE OBSTRUCTION OCCURRED AT THE THREE WAY STOPCOCK. THE STOPCOCK WAS REPLACED WITH ANOTHER STOPCOCK, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DEVICE WAS RETURNED FOR EVALUATION. THE EVENT WAS CONFIRMED; THERE WAS AN OCCLUSION WITHIN THE SIDEPORT EXTENSION. THE CAUSE OF THE INFLATION DIFFICULTY WAS DUE TO AN UNKNOWN OCCLUSION WITHIN THE LUER ADAPTOR OF THE SIDE PORT. THE ROOT CAUSE OF THE OCCLUSION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, MOST LIKELY OCCURRED DURING SUPPLIER MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591499 RELIANT CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 0007105908

    Patients

    Seq Age Sex Outcome Treatment
    1