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

Model Number	M00558370
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.H11: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual and microscopic inspection found a longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The balloon torn problem found could have been interpreted by the customer as the reported event of balloon leak.The results of the analysis performed on the returned device found that the longitudinal tear in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during/previous the procedure could create friction on the balloon, causing the problem of torn longitudinal during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed and from the information available, this device was inconsistently used per the instructions for use (ifu)/product label.
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 dilatation procedure to treat gastrointestinal stenosis performed on (b)(6) 2025.During inflation, the pressure increased normally up to 5 atm.However, it failed to rise further, and the balloon did not expand.A pinhole leak was suspected.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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22760883
• Report Number: 3005099803-2025-03771
• Device Sequence Number: 5760181
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: (01)08714729195993(17)261024(10)35136518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 0035136518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/08/2025
• 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