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

Model Number	M00558930
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the bile duct during a stone removal procedure for a bile duct stone performed on (b)(6) 2026.During the procedure, the balloon could not be properly expanded and reportedly ruptured.It was reported that the balloon burst at a pressure/diameter of 3atm/10mm.No piece of balloon detached inside the patient.The procedure was completed with another device there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the distributor.The healthcare facility where the event occurred is: (b)6) hospital.Phone number: (b)(6), fax number: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst block h11: investigation results the returned cre rx dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated without any problem.However, it was not able to hold the pressure due to it had a pinhole in the balloon which produces a failure to inflate, located approximately at 20 mm from the tip of the device.Microscopic inspection confirmed the balloon pinhole.No other problems with the device were noted.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found in the balloon is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

• Brand Name: CRE 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: 24527452
• Report Number: 3005099803-2026-00844
• Device Sequence Number: 8515293
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: (01)08714729965480(17)280911(10)37439400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172520
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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 Model Number: M00558930
• Device Catalogue Number: M00558930
• Device Lot Number: 0037439400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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