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

Model Number	M00558370
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the bsc sales representative.The healthcare facility is: (b)(6) hospital.(b)(6).Phone number: (b)(6).Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2025.During withdrawal, the balloon does not come out of the scope as they should after inflation.It was reported that the balloon was not able to be fully deflated before removing from the patient and had to cut the balloon at the tip of the scope to remove the balloon.The procedure was completed with the original device.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: 23398826
• Report Number: 3005099803-2025-05565
• Device Sequence Number: 9969898
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: (01)08714729195993(17)270613(10)36749603
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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
• Device Lot Number: 0036749603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 06/13/2025
• 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