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	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii syringe was attempted to be used in the main papilla during an endoscopic lithotripsy procedure performed on (b)(6) 2026.During the procedure, the pressure gauge on the device did not increase, making it unclear how many atmospheres of inflation had been achieved.As a result, the balloon was deflated.The procedure was completed using another alliance syringe device.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: at this time the device is currently undergoing technical analysis.The investigation is not yet complete.A supplemental report will be submitted once the results are available.

• 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 ; +1(914)571-6918
• MDR Report Key: 25399454
• Report Number: 3005099803-2026-02317
• Device Sequence Number: 10739334
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)271128(10)38067604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/31/2026

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: M00550601
• Device Lot Number: 0038067604
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2025
• 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