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

Model Number	M00545960
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0402 captures the reportable event of a balloon burst.
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 (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stricture performed on (b)(6) 2025.During the procedure, the balloon was dilated and burst before 3 atms were reached.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 (describe event or problem) and block h6 (device codes) have been updated.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
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 (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stricture performed on (b)(6) 2025.During the procedure, the balloon was dilated and burst before 3 atms were reached.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.***additional information received on october 26, 2025*** it was reported that the balloon was tested before the incident.However, the instructions for use (ifu), states that precaution: do not preinflate, pretest balloon, or attempt to refold balloon into protective sleeve.

• 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: 23347884
• Report Number: 3005099803-2025-05509
• Device Sequence Number: 13126849
• Product Code: FGE
• UDI-Device Identifier: 08714729283874
• UDI-Public: (01)08714729283874(17)270121(10)35673827
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/19/2025

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: M00545960
• Device Catalogue Number: M00545960
• Device Lot Number: 0035673827
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 01/21/2025
• 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 Age: 68 YR
• Patient Sex: Male