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

Model Number	M00545940
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Imdrf device code a0501 captures the reportable event of balloon detachment.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f2301 captures the reportable event of additional device required (grasping forceps).
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat a tight biliary stricture performed on (b)(6) 2025.During the procedure, the balloon was unable to fully deflate, and the balloon sheared off.The physician tried balloon extraction using grasping forceps but was unable to retrieve the deflated balloon from the duct.The patient was stented past the balloon as planned at the start of the procedure and the procedure was completed successfully.No further information has been obtained despite good faith efforts.The balloon remained in the patient, and the patient was given post procedure antibiotics in recovery.

• 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: 23709033
• Report Number: 3005099803-2025-06573
• Device Sequence Number: 18821437
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: (01)08714729283850(17)260730(10)34534627
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2026
• Device Model Number: M00545940
• Device Catalogue Number: M00545940
• Device Lot Number: 0034534627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 07/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown