MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PNEUMATIC INFLATOR; CATHETER, BALLOON TYPE

Model Number	M00553200
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was attempted to be used in the cardiac region during an esophageal dilation procedure to treat esophageal achalasia performed on (b)(6) 2026.During the procedure, the device was used for a second achalasia dilation procedure.It was report that air was being injected into the balloon; however, the pressure gauge did not rise.It was reported that there were no alternative products available, they performed the procedure under fluoroscopy and completed it with the same original device.There were no patient complications reported as a result of this event.

• Brand Name: PNEUMATIC INFLATOR
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25234089
• Report Number: 3005099803-2026-01991
• Device Sequence Number: 10357330
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: (01)08714729195450(11)251103(10)37858406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K781772
• 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): 05/20/2026

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: M00553200
• Device Catalogue Number: M00553200
• Device Lot Number: 0037858406
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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