MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number	M00558370
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: detailed product information was not provided to bsc.The lot number was reported to be not available per account.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a041001 captures the reportable event of a balloon pinhole in the esophagus.
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 performed on an unknown date.During the procedure, the device popped and had two different small holes where water was leaking.It was reported that no piece of the balloon detached inside the patient.The procedure was completed using another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

• 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 ; 9145716918
• MDR Report Key: 25059611
• Report Number: 3005099803-2026-01617
• Device Sequence Number: 9426916
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: (01)08714729195993
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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: M00558370
• Device Catalogue Number: M00558370
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/01/2026; 06/04/2026
• 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