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

Model Number	M00558650
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilatation procedure performed on (b)(6) 2025.During the procedure, when inflating the device at 6 atm, the balloon burst.It was reported that no piece of the balloon was detached and fell inside the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilatation procedure performed on (b)(6) 2025.During the procedure, when inflating the device at 6 atm, the balloon burst.It was reported that no piece of the balloon was detached and fell inside the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.Additional information received on january 12, 2026.The type of procedure performed was gastroscopy with dilatation for esophageal stricture treatment and the procedure was completed using another of the same cre pro wireguided dilatation balloon.
Additional Manufacturer Narrative
Block h2: additional information block b5 (describe event or problem) has been updated based on the information received on january 12, 2026.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilatation procedure performed on (b)(6) 2025.During the procedure, when inflating the device at 6 atm, the balloon burst.It was reported that no piece of the balloon was detached and fell inside the patient.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.Additional information received on january 12, 2026.The type of procedure performed was gastroscopy with dilatation for esophageal stricture treatment and the procedure was completed using another of the same cre pro wireguided dilatation balloon.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results.The returned cre pro wireguided dilatation balloon was analyzed, and a visual and microscopic inspection found that the balloon was torn longitudinally.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The returned balloon was found torn longitudinally.The torn balloon problem found could have been interpreted by the customer as the reported event of a balloon burst.The problem found is likely to have occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: CRE PRO
• 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: 23914210
• Report Number: 3005099803-2025-06917
• Device Sequence Number: 9194554
• Product Code: FGE
• UDI-Device Identifier: 08714729797531
• UDI-Public: (01)08714729797531(17)280306(10)36014338
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K112994
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: M00558650
• Device Catalogue Number: M00558650
• Device Lot Number: 0036014338
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/13/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/30/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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