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

Model Number	M00545920
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat pancreatic duct stones performed on (b)(6) 2025.During the procedure, the device was inflated to one atmospheric pressure inside the body's patient and the balloon burst.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated prior to use in the patient.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat pancreatic duct stones performed on (b)(6) 2025.During the procedure, the device was inflated to one atmospheric pressure inside the body's patient and the balloon burst.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated prior to use in the patient.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results the returned hurricane rx dilation balloon was analyzed, and a visual inspection found that the balloon was longitudinally torn.Microscopic inspection confirmed the balloon longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The results of the analysis performed on the returned device found that the balloon had a longitudinal tear.It was reported that the balloon was pre-tested; however, the ifu states, precaution: do not pre-inflate, pretest balloon, or attempt to refold balloon into protective sleeve.Testing the balloon previously can cause the balloon to lose its original shape causing resistance when inserting it into the scope and can cause the longitudinal torn found on the balloon.Therefore, the most probable root cause is failure to follow instructions.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label.It was reported that the balloon was pre-tested; however, the ifu states, precaution: do not pre-inflate, 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: 22610982
• Report Number: 3005099803-2025-03535
• Device Sequence Number: 20198088
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: (01)08714729283836(17)260829(10)34742202
• 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,Followup
• Report Date (Section B): 10/21/2025

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: 08/29/2026
• Device Model Number: M00545920
• Device Catalogue Number: M00545920
• Device Lot Number: 0034742202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 51 KG