BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE RX

    MDR report key: 8407768 · Received March 11, 2019

    Report

    Report Number
    3005099803-2019-01077
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283805
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H11: CORRECTION BLOCK B5, H6 AND H10 BLOCK B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2019 AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PROBLEM CODE 1074 CAPTURES THE REPORTABLE EVENT OF BALLOON BURST. BLOCK H10: 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 · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON PART BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. CORRECTION: A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2019 AS NO EVENT DATE WAS REPORTED. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. 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 TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON PART BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200708 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545890 08714729283805

    Patients

    Seq Age Sex Outcome Treatment
    1