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

Model Number	M00545940
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the balloon catheter broke off, leaving the balloon stuck in the patient's common bile duct (cbd).It was reported that the balloon was being used off-label in attempts to dilate the cbd and remove a migrated plastic stent.It was reported that balloon and part of the catheter, including visible radiopaque markers, had broken off and was lodged in the cbd.The balloon has been left in the patient, who was not scheduled for removal or surgery due to their overall health condition.A photo of the device was provided by the customer and showed that the catheter was broken.The procedure was not completed due to this event.No known complications at the time it was reported but the device remained stuck in the patient.The patient was admitted to palliative care for their terminal condition and has passed away.According to the physician's assessment, there was no relationship between the malfunction of the hurricane balloon and the patient's death.The patient had metastatic cancer, but the hospital was unable to provide any specifics.The patient was on hospice/palliative care.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 is being used to capture the reportable event of unretrieved device fragment.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the balloon catheter broke off, leaving the balloon stuck in the patient's common bile duct (cbd).It was reported that the balloon was being used off-label in attempts to dilate the cbd and remove a migrated plastic stent.It was reported that balloon and part of the catheter, including visible radiopaque markers, had broken off and was lodged in the cbd.The balloon has been left in the patient, who was not scheduled for removal or surgery due to their overall health condition.A photo of the device was provided by the customer and showed that the catheter was broken.The procedure was not completed due to this event.No known complications at the time it was reported but the device remained stuck in the patient.The patient was admitted to palliative care for their terminal condition and has passed away.According to the physician's assessment, there was no relationship between the malfunction of the hurricane balloon and the patient's death.The patient had metastatic cancer, but the hospital was unable to provide any specifics.The patient was on hospice/palliative care.***correction noted on january 13, 2025*** note: the indication in the instructions for use (ifu) states: the hurricane rx biliary balloon dilatation catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the sphincter of oddi.The hurricane rx biliary balloon dilatation catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.However, it was reported that the balloon was being used off-label in attempts to dilate the cbd and sweep a migrated plastic stent out of the cbd.
Additional Manufacturer Narrative
Block b5 (describe event or problem) and block h6 (device codes) have been corrected.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2008 is being used to capture the reportable event of unretrieved device fragment.Imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21048713
• Report Number: 3005099803-2024-06713
• Device Sequence Number: 3409141
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: 08714729283850
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/31/2025

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: M00545940
• Device Catalogue Number: M00545940
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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 Sex: Unknown