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	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address (b)(6); reported here as the address exceeded the character limit for the designated field.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.Imdrf impact code f1001 is being used to capture the reportable event of a canceled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use during an esophageal dilation procedure performed on (b)(6) 2025.During preparation, the syringe did not generate the necessary pressure for use.The pressure gauge needle would rise but it automatically decreased.The device was never used on the patient.The procedure was canceled after patient sedation and is currently pending rescheduling.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 has been corrected based on the information received on april 21, 2025.Block e1: initial reporter address 1 is (b)(6); reported here as the address exceeded the character limit for the designated field.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.Imdrf impact code f1001 is being used to capture the reportable event of a canceled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use during an esophageal dilation procedure performed on (b)(6) 2025.During preparation, the syringe did not generate the necessary pressure for use.The pressure gauge needle would rise but it automatically decreased.The device was never used on the patient.The procedure was canceled after patient sedation and is currently pending rescheduling.There were no patient complications reported as a result of this event.Additional information received on april 21, 2025.It was reported that mfr report # 3005099803-2025-01906 alliance syringe and mfr report # 3005099803-2025-01952 cre pro wireguided dilatation balloon were used in the same patient with same procedure and are related.

• 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: 21938334
• Report Number: 3005099803-2025-01906
• Device Sequence Number: 17478605
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)250418(10)31457287
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/14/2025

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: 04/18/2025
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0031457287
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 04/19/2023
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG