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

Model Number	M00558700
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two cre pro wireguided dilatation balloon device used in the same patient and procedure.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloon devices were used in the esophagus during a dilation procedure for treatment of a stricture on (b)(6) 2025 during the procedure, the balloon burst at 16.5 mm size.It was reported that no piece of the balloon detached inside the patient additionally, the same problem happened on the other cre pro wireguided dilatation balloon device.The procedure was completed with another cre pro wireguided dilatation balloon.The procedure was prolonged as a result of these events; however, the amount of additional procedure time could not be obtained and was reported to be unavailable by the customer/account.There were no patient complications have been reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

• 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: 24186074
• Report Number: 3005099803-2026-00310
• Device Sequence Number: 9600168
• Product Code: FGE
• UDI-Device Identifier: 08714729797586
• UDI-Public: (01)08714729797586(17)280826(10)37316037
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 01/26/2026

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: M00558700
• Device Catalogue Number: M00558700
• Device Lot Number: 0037316037
• 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: 01/02/2026
• Initial Report FDA Received Date: 01/26/2026
• Date Device Manufactured: 08/27/2025
• 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