BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HURRICANE RX

    MDR report key: 10532284 · Received September 14, 2020

    Report

    Report Number
    3005099803-2020-03860
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 1, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283836
    PMA / PMN Number
    K001338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2020 AS NO EVENT DATE WAS REPORTED. BLOCK H6: PROBLEM CODE 2907 CAPTURES THE REPORTABLE EVENT OF RX TUNNEL DETACHED. BLOCK H10: INVESTIGATION RESULTS VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THE BALLOON DID NOT SHOW VISUAL DEFECTS AND WAS IN A GOOD CONDITION. NO DAMAGE FOUND ON THE CATHETER OF THE DEVICE. THROUGH HIGH MAGNIFICATION A HOLE WAS NOTICED IN THE BODY OF THE BALLOON. THE RX TUNNEL WAS PRESENT ON THE DEVICE. FUNCTIONAL ANALYSIS WAS ATTEMPTED TO BE PERFORMED; HOWEVER, THE BALLOON LUMEN WAS OCCLUDED AND COULD NOT BE UNBLOCKED. THE REPORTED FAILURE OF BALLOON HOLE WAS ABLE TO BE CONFIRMED, BUT THE REPORTED FAILURE OF RX TUNNEL DETACHMENT WAS UNABLE TO BE CONFIRMED. THIS FAILURE IS LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN, THE INTERACTION WITH THE SCOPE, AND NORMAL PROCEDURAL DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE, THAT COULD HAVE AFFECTED DEVICE PERFORMANCE AND ITS INTENDED PURPOSE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BLOCK H11: CORRECTION BLOCK H1 (TYPE OF REPORTABLE EVENT).

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATION BALLOON WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT BOTH BALLOONS HAD A HOLE AND COULD NOT BE INFLATED. ADDITIONALLY, THE BLACK SLEEVES OF THE DEVICES DETACHED INSIDE THE PATIENT AND WERE RETRIEVED WITH A GRASPER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2020 AS NO EVENT DATE WAS REPORTED. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATION BALLOON WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT BOTH BALLOONS HAD A HOLE AND COULD NOT BE INFLATED. ADDITIONALLY, THE BLACK SLEEVES OF THE DEVICES DETACHED INSIDE THE PATIENT AND WERE RETRIEVED WITH A GRASPER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992532 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545920 0025518316 08714729283836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention