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

Model Number	M00545900
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the ampulla and bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat cholangiocarcinoma on (b)(6) 2025.During the procedure, the physician used a balloon to dilate the left hepatic duct.The wire was left in place for stent placement later.After dilation, the physician pulled the catheter out so he could send another wire and dilating balloon into the right hepatic.Once the catheter passed through the scope and out the tip to re cannulate the duct, it was noticed that a black portion of the previous catheter in the duct over the first wire.It was reported that the detached piece was completely retrieved upon pulling out the scope.The procedure was completed with another of the same device there were no patient complications reported as a result of this event.Note: photo of the device outside the patient provided by the customer shows the rx tunnel of the device and catheter kinked.

• 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: 23000766
• Report Number: 3005099803-2025-04546
• Device Sequence Number: 18495134
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)270220(10)35900047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/08/2025

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: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0035900047
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 02/20/2025
• 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