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

Model Number	M00545890
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	02/12/2025
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 attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the balloon was advanced through viabil, and was able to be inflated once, while filling it the second time, the balloon burst around 2-3atm.The same problem occurred with the second hurricane rx dilatation balloon.It was reported there was viabil stent in the duct and no piece of the balloon detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2 (correction): block d4 (lot number) has been corrected.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was inflated without any problem; however, it was not able to hold the pressure due to it had some pinholes in the balloon located approximately at 10 and 25 mm from the tip of the device.Microscopic inspection confirmed the balloon pinhole.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 pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found is likely to have 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 to 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.
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 attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the balloon was advanced through viabil, and was able to be inflated once, while filling it the second time, the balloon burst around 2-3atm.The same problem occurred with the second hurricane rx dilatation balloon.It was reported there was viabil stent in the duct and no piece of the balloon detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21529840
• Report Number: 3005099803-2025-00873
• Device Sequence Number: 8334616
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: (01)08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: M00545890
• Device Catalogue Number: M00545890
• Device Lot Number: 0035315296
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Race: White