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	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use in the esophagus during a dilation procedure to treat stenosis performed on (b)(6) 2026.During preparation, the gauge does not show the pressure of the balloon during inflation.The same problem occurred with the second balloon with different lot number.The procedure was not completed and was canceled; however, the patient was not sedated when the procedure was canceled.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 inflation device gauge reading inaccurate.Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.The exact device expiration date is unknown; however, it was reported that the device was not expired.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use in the esophagus during a dilation procedure to treat stenosis performed on (b)(6) 2026.During preparation, the gauge does not show the pressure of the balloon during inflation.The same problem occurred with the second balloon with different lot number.The procedure was not completed and was canceled; however, the patient was not sedated when the procedure was canceled.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 inflation device gauge reading innacurate.Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.The exact device expiration date is unknown; however, it was reported that the device was not expired.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.Block h11: investigation results the device was not returned for analysis and was reported to be not available for return; therefore, a technical analysis could not be performed.Media inspection of the device photo showed evidence of inaccurate reading.With all available information, boston scientific concludes the reported event of gauge reading inaccurate was confirmed.The results of the media analysis performed on the not returned device found evidence of inaccurate readings from the video attached.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.A risk review was completed and confirmed that the event of gauge reading inaccurate and cancelled/rescheduled - pre-sedation/no sedation was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu 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: 24531255
• Report Number: 3005099803-2026-00848
• Device Sequence Number: 8972006
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: (01)08714729746737
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/25/2026

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: M00550600
• Device Catalogue Number: M00550600
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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