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	09/05/2025
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 during an esophagogastroduodenoscopy (egd) with pneumatic dilation procedure in the gastroesophageal junction performed on (b)(6) 2025.During the procedure, the pneumatic hand pump was prepared and connected for balloon insufflation.During the insufflation step, multiple pumping attempts were made however, the manometer dial did not register any pressure, and the needle remained at zero throughout.Due to the lack of pressure indication and uncertainty regarding balloon inflation, the pump was removed from use to mitigate any risk to the patient.The procedure was completed with another pneumatic inflator and with the same rigiflex dilatation balloon.Following the procedure, the defective pneumatic pump was tested.All luer fittings were checked for tightness, and the gauge was lightly tapped to assess for needle movement.No leaks, hissing sounds, or balloon expansion were observed during this testing.The gauge continued to show no response.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic inflator was attempted to be used during an esophagogastroduodenoscopy (egd) with pneumatic dilation procedure in the gastroesophageal junction performed on (b)(6) 2025.During the procedure, the pneumatic hand pump was prepared and connected for balloon insufflation.During the insufflation step, multiple pumping attempts were made however, the manometer dial did not register any pressure, and the needle remained at zero throughout.Due to the lack of pressure indication and uncertainty regarding balloon inflation, the pump was removed from use to mitigate any risk to the patient.The procedure was completed with another pneumatic inflator and with the same rigiflex dilatation balloon.Following the procedure, the defective pneumatic pump was tested.All luer fittings were checked for tightness, and the gauge was lightly tapped to assess for needle movement.No leaks, hissing sounds, or balloon expansion were observed during this testing.The gauge continued to show no response.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h11: investigation results.The returned pneumatic inflator was analyzed, and a visual inspection observed the indicator pointing at 20.The indicator remained at 20 during and after inflating a balloon.No inflation problem was noted during functional test.Upon disassembling the handle, it was observed that the spring shifted from its position which caused the indicator to point at 20.Once pushed back to its allocated position the indicator was pointing at zero.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was confirmed.The returned pneumatic inflator was able to inflate a balloon.However, the indicator remained at 20.It was found that the spring inside the handle was displaced, once fixed the indicator was pointing at zero.Based on all gathered information, the most probable cause code is cause traced to component failure, which indicates that the problem is a random or expected problem of the device component, in this case the spring shifted from its position.

• 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: 23184643
• Report Number: 3005099803-2025-04886
• Device Sequence Number: 9992351
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: (01)08714729195450(11)240109(10)33168417
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 0033168417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: Female