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

Model Number	M00545920
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a04 captures the reportable event of balloon damaged.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilatation balloon used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat strictures performed on (b)(6) 2025.It was reported that the balloon broke/fractured.A second hurricane rx dilatation balloon of the same lot was used, and the same problem occurred.It was reported that the procedure was completed with the original method/device used.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 a04 captures the reportable event of balloon damaged.Block h11: the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the balloon had no damages.Functional inspection was performed; the balloon was inflated and able to hold the pressure without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged/defective was not confirmed.The device was carefully inspected, and no damages were found, for functional inspection, the balloon was inflated and able to hold the pressure without any problem.The analysis of the returned device did not identify any evidence of either the alleged problem or any defect on the device.The investigation findings and all information available concludes the most probable root cause is no problem detected.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilatation balloon used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat strictures performed on (b)(6) 2025.It was reported that the balloon broke/fractured.A second hurricane rx dilatation balloon of the same lot was used, and the same problem occurred.It was reported that the procedure was completed with the original method/device used.No further information has been obtained despite good faith efforts.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: 23213711
• Report Number: 3005099803-2025-05144
• Device Sequence Number: 9066660
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: (01)08714729283836(17)270408(10)36250979
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/02/2026

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: M00545920
• Device Catalogue Number: M00545920
• Device Lot Number: 0036250979
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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