MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Hurricane RX; catheter, biliary, diagnostic

Model Number	M00545900
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481)
Date of Event	08/17/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to boston scientific corporation that imaging revealed a shadow in the pancreatic duct; therefore, a spyscope ds ii, tandem xl, hurricane rx, spybite max, extractor rx retrieval balloon, and trapezoid rx were used for examination during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.Upon examination, intraductal papillary mucinous neoplasm lesions (ipnm) were observed in the pancreatic neck and tail, along with a pancreatic duct stone.A hurricane 4 mm, 4 cm balloon was used to dilate the pancreatic duct.After using the spybite max for biopsy, the physician attempted stone extraction using an extractor balloon and a trapezoid basket, but these attempts were unsuccessful.The physician then attempted to use a hurricane 4 mm, 4 cm balloon to drag the stone out.At the moment traction was applied, the hurricane balloon may have been damaged, and contrast medium was observed flowing into the pancreatic duct.It was uncertain at that time whether any injury to the pancreatic duct had occurred.On (b)(6) the patient developed pancreatitis.On (b)(6) the patient underwent partial pancreatectomy, with resection of the pancreatic neck and tail.On the following day, bleeding at the surgical site was identified while the patient was in the icu.The patient was returned to the operating room, where laparoscopic hemostasis was performed successfully.On (b)(6) the patient developed internal bleeding while in the icu.Resuscitation was performed for approximately one hour; however, the patient did not survive.Note: it was reported that hurricane balloon was used to extract stones due to failure of the extractor balloon to retrieve the stones.However, per the ifu, the device is recommended for endoscopic dilatation of strictures of the biliary tree and the sphincter of oddi.It may also be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of balloon damaged/defective.Imdrf patient code 9210 captures the reportable event of pancreatitis.Imdrf patient code 9130 captures the reportable event of hemorrhage.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f2306 captures the reportable event of resuscitation.Imdrf impact code f02 captures the reportable event of death.

• 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 ; +1(914)571-6918
• MDR Report Key: 50926355
• Report Number: 3005099803-2026-03950
• Device Sequence Number: 14794877
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: (01)08714729283812(17)261016(10)35076550
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 0035076550
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 10/16/2024
• 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: Death
• Patient Sex: Female