BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE RX

    MDR report key: 8051445 · Received November 8, 2018

    Report

    Report Number
    3005099803-2018-61137
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT# 3005099803-2018-61138 FOR THE SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND MFR REPORT# 3005099803-2018-61137 FOR THE HURRICANE RX. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A HURRICANE RX WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN USED THE SPYSCOPE DS TO VISUALIZE A LARGE PANCREATIC STONE FOR EHL. DURING DEVICE EXCHANGE, HE NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS WAS PROTRUDING. A GUIDEWIRE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED AND THERE REPORTED ISSUES WITH THE GUIDEWIRE. WHEN THE HURRICANE RX WAS ALSO USED WHILE DILATING THE PANCREATIC DUCT STRICTURE, THE BALLOON BURST. REPORTEDLY, NO PART OF THE DEVICES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND A SECOND HURRICANE RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890628 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1