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

Model Number	M00545920
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by a nurse manager gek leng tan.The healthcare facility details are unknown.Imdrf device code a0414 captures the reportable investigation result of balloon longitudinally torn.Block h11: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual and microscopic inspection found that the balloon was longitudinally torn, which leads to the reported failure to inflate.No other problems with the device were noted.The results of the analysis performed on the returned device found that the balloon was longitudinally torn, which leads to the reported balloon failure to inflate.The torn longitudinal found in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during/previous the procedure could create friction on the balloon, causing the problem of torn longitudinal found.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was attempted to be used during a procedure.The exact procedure date is unknown.During the procedure, the balloon would not inflate.The procedure was completed using an alternative device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon longitudinally torn.Please see block h11 for full investigation details.

• 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: 21687705
• Report Number: 3005099803-2025-01190
• Device Sequence Number: 18355328
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: 08714729283836
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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 Expiration Date: 03/15/2026
• Device Model Number: M00545920
• Device Catalogue Number: M00545920
• Device Lot Number: 0033639461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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