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

Model Number	M00558360
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The reported healthcare facility is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a 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 esophageal stenosis dilation procedure performed for the treatment of esophageal cancer on (b)(6) 2025.During the procedure, the balloon was inflated to 15mm using an indeflator at 7 atm, but the balloon burst.The procedure was completed with another cre fixed wire 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 sales representative.The reported healthcare facility is: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual evaluation found the balloon teared.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of balloon burst could not be confirmed.The teared problem found could have been interpreted by the customer as the reported event of balloon burst.It is possible that the teared found in the balloon occurred due to procedural factors such as excess pressure or interaction with other devices.Additionally, interaction with a sharp surface during or prior to the procedure could have caused the failure observed in the balloon.Therefore, the most probable root cause is adverse event related to procedure.
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 esophageal stenosis dilation procedure performed for the treatment of esophageal cancer on (b)(6) 2025.During the procedure, the balloon was inflated to 15mm using an indeflator at 7 atm, but the balloon burst.The procedure was completed with 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: 23215979
• Report Number: 3005099803-2025-05151
• Device Sequence Number: 18410933
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: (01)08714729195986(17)270415(10)36305600
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: M00558360
• Device Catalogue Number: M00558360
• Device Lot Number: 0036305600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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