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

Model Number	M00545940
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilation balloon was used in the bile duct during a choledocholithotomy procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, an attempt was made to dilate the duodenal papilla using the device.It was reported that the balloon did not expand to the intended dilation pressure.The device was removed and inspected and found out that the balloon had ruptured.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilation balloon was used in the bile duct during a choledocholithotomy procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, an attempt was made to dilate the duodenal papilla using the device.It was reported that the balloon did not expand to the intended dilation pressure.The device was removed and inspected and found out that the balloon had ruptured.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.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.H11: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual inspection found no physical damage.Functional evaluation found the balloon was inflated without any problem; however, it was not able to hold the pressure due to a pinhole located approximately at 11 mm from the tip of the device.Microscopic inspection also found evidence of pinhole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst cannot be confirmed.The balloon pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The results of the analysis performed on the returned device found that the pinhole located approximately at 11 mm from the tip of the device which causes the balloon unable to inflate.The pinhole found in the balloon occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 23551509
• Report Number: 3005099803-2025-05915
• Device Sequence Number: 9683567
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: (01)08714729283850(17)270722(10)37026369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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 Model Number: M00545940
• Device Catalogue Number: M00545940
• Device Lot Number: 0037026369
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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