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); Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2025
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 ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide wire was successfully positioned in the right bile duct, allowing the placement of a hurricane dilation balloon to expand the stenosis at the hilum.However, after inflation, the balloon failed to deflate and remained inflated.Attempts to mobilize it led to the sheath breaking, leaving the balloon trapped in the right bile duct.Efforts to retrieve it using pediatric forceps were unsuccessful.The doctor then opted to complete the procedure by placing a hepatic gastric tube in the liver and a metal stent at the lower bile ducts, hoping to later access it via a spyscope.However, in the following days, the tumor's progression to the bile ducts led to a worsening of the patient's condition, necessitating palliative care.The planned spyglass procedure on (b)(6) 2025 to recover the balloon was ultimately canceled.It was reported that the patient was hospitalized and was sent for palliative care.The patient died on (b)(6) 2025, due to his current medical condition of metastatic cholangiocarcinoma.Per the facility, the detached balloon was still in place but does not appear to have contributed to his death.
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 device code a140101 captures the reportable event of balloon failure to deflate.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 additional device required.Imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.

• 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: 22199893
• Report Number: 3005099803-2025-02626
• Device Sequence Number: 18059299
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: (01)08714729283850(17)260523(10)34094065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• 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: 0034094065
• 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: 05/14/2025
• Initial 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: Male