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

Model Number	M00545900
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of three hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the hilum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, while dilating, the balloon ruptured and leaked.A second and third balloon device were attempted to be used but both balloons also ruptured and leaked.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a step dilator.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results: the returned hurricane rx dilatation balloon was analyzed and a visual inspection found no physical damage.A functional evaluation found the balloon inflated without problems but was not able to hold pressure due to pinholes in the balloon.Microscopic evaluation found the balloon had pinholes located approximately 10mm and 12mm from the tip of the device.Also, after a destructive test, the balloon was cut, and it was possible to identify the proper glue on the ro markers.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed.The returned device was inflated without problems however it was not able to hold pressure due to pinholes located approximately 10mm and 12mm from the tip of the device.Also, after a destructive test, the balloon was cut, and it was possible to identify the proper glue on the ro markers.It is possible that the pinholes found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices, or anatomical factors.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the pinholes.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
Note: this report pertains to one of three hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used in the hilum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, while dilating, the balloon ruptured and leaked.A second and third balloon device were attempted to be used but both balloons also ruptured and leaked.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a step dilator.There were no patient complications reported as a result of this event.

• 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: 22003492
• Report Number: 3005099803-2025-02044
• Device Sequence Number: 7238445
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)261204(10)35415486
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/23/2025

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: 0035415486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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 Sex: Unknown