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

Model Number	M00545900
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of balloon torn circumferentially.Block e1: initial reporter facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h11: investigation results the returned hurricane rx balloon was analyzed, and a visual and microscopic inspection found evidence that the balloon was torn circumferentially.No other problems with the device were noted.The results of the analysis performed on the returned device found that the balloon had a circumferential tear which leads to a leakage.It is possible that the circumferential tear found in the balloon occurred due to procedural factors such as excess of 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 failure found on the balloon.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
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) and metal stent implantation procedure for stenosis of the upper and middle segment performed on (b)(6) 2026.During the procedure, the balloon leaked.The procedure was completed with another of the same model.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 stable.This event has been deemed a reportable event based on the investigation finding of balloon torn.Please see block h11 for full investigation details.

• 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: 24689564
• Report Number: 3005099803-2026-01091
• Device Sequence Number: 21326239
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)270124(10)35703908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/25/2026

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: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0035703908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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