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

Model Number	M00545940
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the balloon and catheter detached in the patient's bile duct.Attempted to remove the broken balloon floating in duct using sweep technique with 12-15, 15-18 stone extraction balloons, right angle forceps, rat tooth forceps and basket; however, it was unsuccessful.The physician ended the procedure after several attempts of retrieval and placed a covered metal stent to guarantee drainage with broken balloon still in duct.It was reported that the patient will be brought back for second ercp to utilize spyglass to attempt retrieval.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon detached.Imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f2301 is being used to capture the reportable event of stone extraction balloons, right angle forceps, rat tooth forceps and basket used in an attempt to retrieve the detached balloon.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon detached.Imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f2301 is being used to capture the reportable event of stone extraction balloons, right angle forceps, rat tooth forceps and basket used in an attempt to retrieve the detached balloon.Block h11: the hurricane rx dilatation balloon device was not returned for analysis.Therefore, a technical analysis could not be performed.However, a media analysis was performed on the photo of the device provided by the complainant.The photo revealed that the balloon was detached.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon detachment of device or device component was confirmed.However, due to lack of evidence, the reported event of catheter break was not confirmed.According to the photo provided by the customer the balloon was detached.There is not enough evidence to determine whether the balloon detached, and catheter break were due to the physician's manipulation/technique during the procedure or related to a device malfunction.Therefore, the most probable cause of this complaint is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the balloon and catheter detached in the patient's bile duct.Attempted to remove the broken balloon floating in duct using sweep technique with 12-15, 15-18 stone extraction balloons, right angle forceps, rat tooth forceps and basket; however, it was unsuccessful.The physician ended the procedure after several attempts of retrieval and placed a covered metal stent to guarantee drainage with broken balloon still in duct.It was reported that the patient will be brought back for second ercp to utilize spyglass to attempt retrieval.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: 21972156
• Report Number: 3005099803-2025-02060
• Device Sequence Number: 8492687
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: (01)08714729283850(17)260523(10)34094061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2026
• Device Model Number: M00545940
• Device Catalogue Number: M00545940
• Device Lot Number: 0034094061
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown