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

Model Number	M00550601
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 during a procedure performed on (b)(6) 2025.During the procedure, when the product was unpacked, the meter had already exceeded the maximum value from the start.The procedure was completed with another 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 during a procedure performed on (b)(6) 2025.During the procedure, when the product was unpacked, the meter had already exceeded the maximum value from the start.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 a0902 captures the reportable event of gauge reading inaccurate.Block h11: investigation results the returned alliance ii inflation syringe was analyzed, and a visual evaluation noted the meter was found exceeded the maximum value (12 atm).Also, the syringe and the extension tube were returned most likely with dry contrast media.A functional inspection was performed, the syringe was connected to an alliance inflation system, the syringe was filled with water, but pressure gauge needle was not decreasing.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 confirmed.The returned device was inspected, the meter had already exceeded the maximum value, and functional testing found the pressure gauge needle not decreasing.The way in which the device was handled and manipulated, such as a possible hit on the gauge or an accidental drop of the device, may have caused the problem.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 21755947
• Report Number: 3005099803-2025-01369
• Device Sequence Number: 8220801
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)260822(10)34691204
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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 Expiration Date: 08/22/2026
• Device Model Number: M00550601
• Device Catalogue Number: M00550601
• Device Lot Number: 0034691204
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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