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	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by the bsc sales representative.The healthcare facility is: (b)(6) hospital.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 an esophageal stricture dilation in the esophagus procedure to treat postoperative esophageal stricture performed on an unknown date.During the procedure, the product was used as usual; however, the gauge did not rise.The procedure was completed with another alliance ii inflation syringe.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h2 (additional information): block e1 (initial reporter last name, initial reporter facility name, initial reporter address, initial reporter city, initial reporter state, initial reporter country, initial reporter zip/post code, initial reporter phone number, and initial reporter fax number) have been updated.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 an esophageal stricture dilation in the esophagus procedure to treat postoperative esophageal stricture performed on an unknown date.During the procedure, the product was used as usual; however, the gauge did not rise.The procedure was completed with another alliance ii inflation syringe.No further information has been obtained despite good faith efforts.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 an esophageal stricture dilation in the esophagus procedure to treat postoperative esophageal stricture performed on an unknown date.During the procedure, the product was used as usual; however, the gauge did not rise.The procedure was completed with another alliance ii inflation syringe.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by the distributor.The healthcare facility is: (b)(6).Phone number:(b)(6).Fax number: (b)(6).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 to the device.Functional inspection was performed, the syringe was connected to an alliance inflation system, filled with water, and pressurized to 10 atm for 30 seconds.It read accurately without any issue.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 results of the analysis performed on the returned device found that the device can be pressurized to 10 atm for 30 seconds, it read accurately without any problem.Therefore, 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: 23000775
• Report Number: 3005099803-2025-04574
• Device Sequence Number: 9413928
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)270325(10)36144619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2025

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: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0036144619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 11/04/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/06/2025; 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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