MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545900
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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 a hurricane rx dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stricture performed on (b)(6) 2025.During the procedure, the hurricane rx dilatation balloon burst before even 3 atms were reached.It was reported that no part of the balloon detached and fell into the patient.The same problem occurred with the second hurricane rx dilatation balloon.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results the returned hurricane rx dilation balloon was analyzed, and a visual and microscopic inspection found that the balloon was longitudinally torn.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The results of the analysis performed on the returned device found that the balloon had a longitudinal tear.The problem found could have occurred due to procedural factors such as excess of pressure or interaction with other devices.It is also possible that the interaction with a sharp surface during or previous the procedure was encountered.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
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 a hurricane rx dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stricture performed on (b)(6) 2025.During the procedure, the hurricane rx dilatation balloon burst before even 3 atms were reached.It was reported that no part of the balloon detached and fell into the patient.The same problem occurred with the second hurricane rx dilatation balloon.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: HURRICANE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23215964
• Report Number: 3005099803-2025-05021
• Device Sequence Number: 8791312
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)260715(10)34433834
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K130484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2026
• Device Model Number: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0034433834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown