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

Model Number	M00550601
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	07/21/2025
Type of Reportable Event	Malfunction
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 upper endoscopy dilation procedure to treat a stricture performed on (b)(6) 2025.During the procedure, the lead technician started to dilate to the first size.The gauge did not move, and the syringe leaked.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a device leak in the esophagus.Imdrf device code a0902 captures the reportable event of gauge reading inaccurate.
Additional Manufacturer Narrative
Correction: block h6 (imdrf device code) has been corrected.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h11: investigation results the returned alliance ii inflation syringe was analyzed, and a visual inspection found no damages with the device.A functional inspection was performed, the syringe was connected to an alliance inflation system, the syringe was filled with water and pressurized to 10 atm; however, it was not able to hold the pressure due to it was leaking at the y-connector section.Microscopic inspection found evidence of leak.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of gauge reading inaccuracy was not confirmed.The syringe was connected to an alliance inflation system, the syringe was filled, and pressure gauge needle was increasing.On the other hand, the device leak is likely to have occurred due to the manner in the device was handled and manipulated may have caused the reported and encountered problem.Excessive manipulation of the device without enough care could have induced the defect found.Therefore, the most probable root cause is an adverse event related to procedure.
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 upper endoscopy dilation procedure to treat a stricture performed on (b)(6) 2025.During the procedure, the lead technician started to dilate to the first size.The gauge did not move, and the syringe leaked.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: block d4 (model number) has been corrected.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurate.Block h11: investigation results.The returned alliance ii inflation syringe was analyzed, and a visual inspection found no damages with the device.A functional inspection was performed, the syringe was connected to an alliance inflation system, the syringe was filled with water and pressurized to 10 atm; however, it was not able to hold the pressure due to it was leaking at the y-connector section.Microscopic inspection found evidence of leak.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of gauge reading inaccuracy was not confirmed.The syringe was connected to an alliance inflation system, the syringe was filled, and pressure gauge needle was increasing; however, it was not able to hold the pressure due to there was a leak near the y-connector section, and microscope inspection shows evidence of leak also.An investigation to address this problem has been completed.Therefore, the most probable root cause is manufacturing deficiency.
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 upper endoscopy dilation procedure to treat a stricture performed on (b)(6) 2025.During the procedure, the lead technician started to dilate to the first size.The gauge did not move, and the syringe leaked.The procedure was completed with another alliance ii inflation syringe.There were no patient complications reported as a result of this event.

• 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: 22800921
• Report Number: 3005099803-2025-03995
• Device Sequence Number: 7798593
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)261203(10)35405910
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0035405910
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/21/2025; 12/17/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/15/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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