BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE RX

    MDR report key: 8765540 · Received July 5, 2019

    Report

    Report Number
    3005099803-2019-03371
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283836
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2019 AS NO EVENT DATE WAS REPORTED. (B)(4). INVESTIGATION RESULT: A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED A PINHOLE OVER THE PROXIMAL RO MARKER. THE INNER RADIO OPAQUE (RO) MARKERS INSIDE THE BALLOON WERE INSPECTED FOR ANY SHARP EDGE BUT NONE OF THEM SHOWED ABNORMALITIES. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE BALLOON LUMEN WAS OCCLUDED AND IT WAS NOT POSSIBLE TO UNBLOCK. THE FAILURE FOUND ON THE DEVICE MAY BE RELATED TO FACTORS ENCOUNTERED DURING THE PROCEDURE AND/OR RELATED TO THE HANDLING/MANIPULATION; HOWEVER, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A HURRICANE RX DILATION BALLOON. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559173 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545920 0023324902 08714729283836

    Patients

    Seq Age Sex Outcome Treatment
    1