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); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: mdrf device code a041001 captures the reportable event of balloon inflation device inaccurate reading.
Event or Problem Description
It was reported to boston scientific corporation that a pneumatic hand pump inflation device was attempted to be used during a balloon dilation procedure for esophageal dilation in the esophagus performed on (b)(6) 2026.During the procedure, the pressure gauge did not function properly.Air leakage was observed, resulting in the inability to maintain pressure.Consequently, the gauge reading was unreliable.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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; model farm road; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25119331
• Report Number: 3005099803-2026-01680
• Device Sequence Number: 9293039
• Product Code: GBA
• UDI-Device Identifier: 08714729195450
• UDI-Public: (01)08714729195450(11)250430(10)36409544
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K781772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2026

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: 0036409544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 07/24/2026; 07/24/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 08/14/2026; 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown