MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number	5060-05
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
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 an alliance ii inflation syringe was attempted to be used in the esophagus during an endoscopic esophageal dilatation procedure to treat esophageal stenosis performed on (b)(6) 2025.During the procedure, the device was used during an esophageal stenosis dilation.The balloon was injected with the inflation medium and no problem with the endoscopic images or balloon inflation.It was reported that the pressure gauge on the device remained at less than 1 atm (around 0.5 atm) and did not rise any further.The balloon inflation was continued while monitoring the inflation status by endoscopic images.The procedure was completed with the original alliance ii inflation syringe.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used in the esophagus during an endoscopic esophageal dilatation procedure to treat esophageal stenosis performed on (b)(6) 2025.During the procedure, the device was used during an esophageal stenosis dilation.The balloon was injected with the inflation medium and no problem with the endoscopic images or balloon inflation.It was reported that that the pressure gauge on the device remained at less than 1 atm (around 0.5 atm) and did not rise any further.The balloon inflation was continued while monitoring the inflation status by endoscopic images.The procedure was completed with the original alliance ii inflation syringe.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 result) the returned alliance ii inflation syringe was analyzed, and a visual evaluation found no physical damage on the device.Functional inspection shows that the syringe gauge reads accurately.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of gauge reading inaccurate was not confirmed.The device was carefully inspected, and no problems were found.Functional inspection shows that the syringe was connected to an alliance inflation system, the syringe was filled with water and pressurized to 10 atm for 30 seconds and reads accurately.Based on all gathered information, the most probable root cause is no problem detected.

• Brand Name: ALLIANCE II
• Common Device Name: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23393948
• Report Number: 3005099803-2025-05647
• Device Sequence Number: 18651689
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)270529(10)36631712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922573
• 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): 12/23/2025

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: 5060-05
• Device Catalogue Number: 5060-05
• Device Lot Number: 0036631712
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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