MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558640
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during a dilation procedure to treat a stricture performed on (b)(6) 2025.During the procedure, the physician was inflating the balloon for subglottic stenosis for a goal inflation of 4.5 mmhg; however, the balloon ruptured during inflation.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the senior clinical risk advisor from medical device safety, pq&s.The healthcare facility where the event occurred is: (b)(6).Phone number: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• 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: 23959956
• Report Number: 3005099803-2026-00024
• Device Sequence Number: 13123726
• Product Code: FGE
• UDI-Device Identifier: 08714729797524
• UDI-Public: (01)08714729797524(17)280424(10)36374339
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: M00558640
• Device Catalogue Number: M00558640
• Device Lot Number: 0036374339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 04/25/2025
• 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