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

Model Number	M00558350
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	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 distal esophagus during a dilation procedure to treat esophageal stricture performed on (b)(6) 2025.During the procedure, the balloon burst at 11mm during balloon inflation.It was reported that no piece of the balloon detached inside the patient.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 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 inspection found that the balloon was longitudinally torn.Microscopic inspection confirmed the balloon longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The results of the analysis performed on the returned device found that the balloon had a longitudinal tear.It is possible that the longitudinally torn found in the balloon occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during/previous the procedure, could have caused the problem found on 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 distal esophagus during a dilation procedure to treat esophageal stricture performed on (b)(6) 2025.During the procedure, the balloon burst at 11mm during balloon inflation.It was reported that no piece of the balloon detached inside the patient.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: 23390416
• Report Number: 3005099803-2025-05593
• Device Sequence Number: 9978984
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: (01)08714729202004(17)261024(10)35136506
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2025

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: M00558350
• Device Catalogue Number: M00558350
• Device Lot Number: 0035136506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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