BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HURRICANE RX

    MDR report key: 22093447 · Received May 28, 2025

    Report

    Report Number
    3005099803-2025-02278
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    April 23, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729283836
    PMA / PMN Number
    K130484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE YEAR OF BIRTH OF THE PATIENT WAS 1962 THEREFORE, PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A020501 CAPTURES THE REPORTABLE EVENT OF FAILURE TO REMOVE BALLOON PROTECTOR SLEEVE. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF MATERIAL SEPARATION. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED (CT SCAN). IMDRF IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY (SECOND ERCP PROCEDURE).

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE BIRTH YEAR OF THE PATIENT WAS 1962 THEREFORE, PATIENT WAS OVER THE AGE OF 18. BLOCK H6: IMDRF DEVICE CODE A020501CAPTURES THE REPORTABLE EVENT OF FAILURE TO REMOVE BALLOON PROTECTOR SLEEVE. IMDRF DEVICE CODE A0413 CAPTURES THE REPORTABLE EVENT OF MATERIAL SEPARATION. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED (CT SCAN). IMDRF IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY (SECOND ERCP PROCEDURE). BLOCK H11: (INVESTIGATION RESULT). THE HURRICANE RX DILATATION BALLOON WAS NOT RETURNED; HOWEVER, PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED BY THE COMPLAINANT. PER MEDIA ANALYSIS, THE PHOTOS SHOWED THAT TWO BALLOON PROTECTIVE SLEEVES DETACHED, WHICH HAVE BEEN REMOVED FROM THE PATIENT'S ANATOMY. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED FROM THE PHOTO. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF DEVICE MATERIAL SEPARATION AND BALLOON PROTECTOR/SLEEVE FAILURE TO REMOVE WAS CONFIRMED. ADDITIONALLY, THE REPORTED EVENT OF PROTECTIVE PLASTIC SHEATH COVERING THE BALLOON WAS UNINTENTIONALLY PUSHED INTO THE BILE DUCTS BY THE PHYSICIAN WAS ALSO CONFIRMED. SINCE THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE WRITTEN INSTRUCTION IN THE IFU THAT STATES: "REMOVE PROTECTIVE SLEEVE FROM BALLOON PRIOR TO INSERTION" AND ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER THAT THE PROTECTIVE PLASTIC SHEATH COVERING THE BALLOON WAS UNINTENTIONALLY PUSHED INTO THE BILE DUCTS BY THE PHYSICIAN (PROTECTIVE SLEEVE DOES NOT MOVE BEFORE INSERTION), THE MOST PROBABLE ROOT CAUSE IS FAILURE TO FOLLOW INSTRUCTION.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN (B)(6) 2024. THE EXACT DAY WAS NOT REPORTED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE STRICTURE BY PLACING A METAL STENT. A HURRICANE RX DILATION BALLOON WAS USED TO ACCESS THE STRICTURE BUT UPON BALLOON DILATION, THE PROTECTIVE PLASTIC SLEEVE COVERING THE BALLOON WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. THE PROTECTIVE SLEEVE SHOULD HAVE BEEN REMOVED DURING PRODUCT UNPACKING. THE SLEEVE WAS NOT VISIBLE UNDER FLUOROSCOPY AND THEREFORE, THE INCIDENT WENT UNNOTICED BY THE HEALTHCARE STAFF. WHEN THE STENT PLACEMENT WAS SUBSEQUENTLY ATTEMPTED, THE STRICTURE COULD NOT BE PASSED, AND THE METAL STENT WAS THEREFORE IMPROPERLY POSITIONED. THE METAL STENT WAS REMOVED, AND DILATION WAS PERFORMED WITH A SECOND HURRICANE RX DILATION BALLOON. DURING THE SECOND DILATATION, A SECOND SLEEVE WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. A METAL STENT WAS THEN SUCCESSFULLY PLACED. AFTER THE ERCP PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS, RESULTING IN ABDOMINAL PAIN AND ELEVATED AMYLASE LEVELS, WHICH PERSISTED FOR APPROXIMATELY 14 DAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHOLANGITIS AND ELEVATED LIVER ENZYME LEVELS. A CT SCAN FOUND AN OCCLUDED METAL STENT AND TWO RETAINED SLEEVES FROM THE BALLOONS INSIDE THE PATIENT. DURING THE SAME ADMISSION, ANOTHER ERCP WAS PERFORMED ON (B)(6) 2025, REVEALING THE METAL STENT WAS BLOCKED BY A LARGE AMOUNT OF BILE DUCT STONES. THE TWO BALLOON SLEEVES WERE LOCATED FURTHER UP IN THE BILE DUCT AND WERE REMOVED FROM THE PATIENT DURING THE PROCEDURE. THE PATIENT DEVELOPED MILD PANCREATITIS AFTER THE SECOND ERCP PROCEDURE BUT IS EXPECTED TO FULLY RECOVER. NOTE: IMAGING PHOTOS OF THE PATIENT WERE PROVIDED AND SHOW TWO BALLOON SLEEVES INSIDE THE PATIENT. PHOTOS OF THE REMOVED SLEEVES OUTSIDE OF THE PATIENT WERE PROVIDED AND SHOWED TWO DETACHED BALLOON PROTECTIVE SLEEVES.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. THE EXACT DAY WAS NOT REPORTED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE STRICTURE BY PLACING A METAL STENT. A HURRICANE RX DILATION BALLOON WAS USED TO ACCESS THE STRICTURE BUT UPON BALLOON DILATION, THE PROTECTIVE PLASTIC SLEEVE COVERING THE BALLOON WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. THE PROTECTIVE SLEEVE SHOULD HAVE BEEN REMOVED DURING PRODUCT UNPACKING. THE SLEEVE WAS NOT VISIBLE UNDER FLUOROSCOPY AND THEREFORE, THE INCIDENT WENT UNNOTICED BY THE HEALTHCARE STAFF. WHEN THE STENT PLACEMENT WAS SUBSEQUENTLY ATTEMPTED, THE STRICTURE COULD NOT BE PASSED, AND THE METAL STENT WAS THEREFORE IMPROPERLY POSITIONED. THE METAL STENT WAS REMOVED, AND DILATION WAS PERFORMED WITH A SECOND HURRICANE RX DILATION BALLOON. DURING THE SECOND DILATATION, A SECOND SLEEVE WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. A METAL STENT WAS THEN SUCCESSFULLY PLACED. AFTER THE ERCP PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS, RESULTING IN ABDOMINAL PAIN AND ELEVATED AMYLASE LEVELS, WHICH PERSISTED FOR APPROXIMATELY 14 DAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHOLANGITIS AND ELEVATED LIVER ENZYME LEVELS. A CT SCAN FOUND AN OCCLUDED METAL STENT AND TWO RETAINED SLEEVES FROM THE BALLOONS INSIDE THE PATIENT. DURING THE SAME ADMISSION, ANOTHER ERCP WAS PERFORMED ON (B)(6) 2025, REVEALING THE METAL STENT WAS BLOCKED BY A LARGE AMOUNT OF BILE DUCT STONES. THE TWO BALLOON SLEEVES WERE LOCATED FURTHER UP IN THE BILE DUCT AND WERE REMOVED FROM THE PATIENT DURING THE PROCEDURE. THE PATIENT DEVELOPED MILD PANCREATITIS AFTER THE SECOND ERCP PROCEDURE BUT IS EXPECTED TO FULLY RECOVER. NOTE: IMAGING PHOTOS OF THE PATIENT WERE PROVIDED AND SHOW TWO BALLOON SLEEVES INSIDE THE PATIENT. PHOTOS OF THE REMOVED SLEEVES OUTSIDE OF THE PATIENT WERE PROVIDED AND SHOWED TWO DETACHED BALLOON PROTECTIVE SLEEVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330333 HURRICANE RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00545920 0035376680 08714729283836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H