MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Fixed Wire; dilator, esophageal

Model Number	M00558360
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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 fixed wire dilatation balloon was attempted to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure for esophageal stricture performed on an unknown date.During procedure, the balloon was advanced from the lowest to the second dilation pressure.As the pressure approached 4 atm and the diameter reached approximately 13.5 mm, the balloon burst inside the patients esophagus.No piece of balloon detached inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be fully recover.

• Brand Name: CRE Fixed Wire
• Common Device Name: dilator, esophageal
• 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 ; +1(914)571-6918
• MDR Report Key: 25773589
• Report Number: 3005099803-2026-02742
• Device Sequence Number: 21240777
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: (01)08714729195986(17)271216(10)38205263
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: M00558360
• Device Catalogue Number: M00558360
• Device Lot Number: 0038205263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 12/16/2025
• 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