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

Model Number	M00550600
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.
Event or Problem Description
Note: this report pertains to one of two alliance ii inflation syringes used in the same patient and procedure.It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, when inflating the balloon, the gauge did not register a pressure reading (atm).Fluid was drawn into the balloon and was confirmed on the fluoroscopic screen; however, no pressure reading was displayed on the gauge.A second syringe device was attempted to be used but it also did not have a pressure reading on the gauge.The procedure was completed with a third alliance ii inflation syringe.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4 have been updated based on additional information received on may 15, 2025 block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.
Event or Problem Description
Note: this report pertains to one of two alliance ii inflation syringes used in the same patient and procedure.It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, when inflating the balloon, the gauge did not register a pressure reading (atm).Fluid was drawn into the balloon and was confirmed on the fluoroscopic screen; however, no pressure reading was displayed on the gauge.A second syringe device was attempted to be used but it also did not have a pressure reading on the gauge.The procedure was completed with a third 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21923013
• Report Number: 3005099803-2025-01829
• Device Sequence Number: 4009247
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: (01)08714729746737(17)261011(10)35045674
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/05/2025

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: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0035045674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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