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

Model Number	M00553200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was used in the lower esophagus during a balloon dilatation procedure to treat achalasia performed on an unknown date.During the procedure, when the device was used, the gauge failed to reach 20 psi even when attempting to inflate to the maximum pressure of 20psi.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of device gauge reading inaccurate.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.H6: imdrf device code a0902 captures the reportable investigation result of gauge reading inaccurate.H11: (investigation results): the returned pneumatic inflator was analyzed, and a visual evaluation noted that the gauge indicator was pointing below zero.Functional test was performed, and the device was able to inflate the balloon and maintain inflation, however, the indicator remained below zero.No other problems with the device were noted.The product analysis revealed that the gauge indicator was pointing below zero.The device was able to inflate a balloon and maintain inflation.However, the indicator was not giving an accurate reading and did not point at zero prior to inflation.Upon disassembling the handle, it was observed that the spring shifted from its position which caused the problem.The device was fixed, and the inflator was able to inflate the ballon and give an accurate reading while maintaining inflation.Based on all gathered information, the most probable root cause is cause traced to component failure.

• 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: 24024248
• Report Number: 3005099803-2026-00139
• Device Sequence Number: 18787565
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: (01)08714729195450(11)250228(10)35961924
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 0035961924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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