BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT

    MDR report key: 3914198 · Received July 3, 2014

    Report

    Report Number
    2953200-2014-01357
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 8, 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). EVALUATION, CONCLUSION: (PENDING DEVICE EVALUATION); EVALUATION, CONCLUSION: (PENDING DEVICE EVALUATION). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE EVENT WAS NOT CONFIRMED; THE DEVICE INFLATED AS EXPECTED AND MET SPECIFICATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A RELIANT BALLOON WAS PLANNED TO BE USED AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN WAS UNABLE TO FLUSH THE RELIANT BALLOON. THERE WAS NO NOTICABLE DAMAGE TO THE PACKAGING OR THE RELIANT BALLOON. THERE WAS NO ADVERSE EVENT TO THE PATIENT SINCE IT WAS UNUSED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER RELIANT BALLOON. THE PHYSICIAN COMMENTED THAT IT SEEMS INFLATION LUMEN MIGHT BE PASSED THROUGH GUIDEWIRE LUMEN, SO INTER LUMEN LEAK IS SUSPECTED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390877 RELIANT CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND 0007060287

    Patients

    Seq Age Sex Outcome Treatment
    1