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

Model Number	M00545900
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the biliary ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the balloon had a pinhole upon inflation at the dilation site contrast solution shot out of the balloon.The balloon was removed, and the procedure was completed with a 6mm hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon longitudinal tear.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of balloon torn longitudinally.Block h11: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual and microscopic inspection found a longitudinal tear on the balloon.No other problems with the device were noted.The returned device revealed the balloon longitudinal tear.It is possible that the tear found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the balloon tear.Therefore, the most probable root cause is 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22036140
• Report Number: 3005099803-2025-02129
• Device Sequence Number: 8214296
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)250731(10)32127313
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 05/16/2025

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: 07/31/2025
• Device Model Number: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0032127313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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