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

Model Number	M00545920
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was being prepared for use in a procedure to be performed on (b)(6) 2025.During preparation, the balloon burst.The procedure was completed with another hurricane rx dilatation balloon.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated before use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 (describe event or problem), block e1 (initial reporter address and zip/post code), and block h6 (device codes) have been updated.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was being prepared for use in a procedure to be performed on (b)(6) 2025.During preparation, the balloon burst.The procedure was completed with another hurricane rx dilatation balloon.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated before use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.***additional information received on july 02, 2025*** it was reported that the type of procedure performed was endoscopic papillary balloon dilation (epbd), and the anatomy location was at the common bile duct.It was reported that the balloon was not pre-inflated outside the patient and no piece of the balloon detached inside the patient.

• 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: 22323174
• Report Number: 3005099803-2025-02838
• Device Sequence Number: 18373858
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: (01)08714729283836(17)261112(10)35262970
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: M00545920
• Device Catalogue Number: M00545920
• Device Lot Number: 0035262970
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 11/12/2024
• 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