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

Model Number	M00545920
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of balloon damaged.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during procedure performed on (b)(6) 2025.It was reported that the balloon was already broken before it entered the patient.The procedure was completed with different device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during procedure performed on (b)(6) 2025.It was reported that the balloon was already broken before it entered the patient.The procedure was completed with different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of balloon damaged.Block h11: investigation results.The returned hurricane rx dilatation balloon was analyzed, and visual inspection found that the sheath was observed to be accordioned.Functional inspection was performed, the balloon was not capable of being inflated as the lumen appeared to be occluded, most likely by dried contrast media.The device was submerged in warm water in an attempt to remove the possible contrast media; however, the problem persisted.X-ray inspection was also performed; the presence of dried contrast media was identified within the catheter lumen.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged/defective was confirmed.Based on the visual inspection performed during device analysis, accordioning of the sheath was observed.This condition is typically associated with excessive compressive, or advancement forces applied to the device during preparation, insertion, or manipulation through the endoscope or anatomical pathway.Such forces may cause the sheath material to buckle and form folds consistent with an accordion-like appearance.Therefore, the observed sheath accordioning is most likely attributable to procedural or handling-related factors rather than a manufacturing-related issue.Functional testing determined that the balloon could not be inflated due to an occlusion within the balloon lumen.X-ray inspection confirmed the presence of dried contrast media within the lumen, which likely obstructed the inflation pathway and prevented balloon expansion.Despite attempts to clear the lumen by submerging the device in warm water, the occlusion persisted.Based on these findings, the reported event of balloon lumen occluded/blocked is most likely attributed to dried contrast media obstructing the balloon lumen, resulting in the inability to inflate the balloon.During the investigation, no evidence of manufacturing-related defects was identified.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of balloon damaged/defective and balloon lumen occluded/blocked were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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 ; 9145716918
• MDR Report Key: 23344658
• Report Number: 3005099803-2025-05438
• Device Sequence Number: 9544770
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: (01)08714729283836(17)260919(10)34881542
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 09/19/2026
• Device Model Number: M00545920
• Device Catalogue Number: M00545920
• Device Lot Number: 0034881542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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