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	11/14/2024
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 used during a dilatation procedure performed on (b)(6) 2024.During the procedure, the dial was faulty and not registering correctly.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 b5 (describe event or problem), block e1 (initial reporter name), block e2 (health professional), and block e3 (occupation) have been updated.Block d5 (operator of device) has 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 used during a dilatation procedure performed on (b)(6) 2024.During the procedure, the dial was faulty and not registering correctly.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.Additional information received on december 05, 2024: it was reported that the type of procedure performed was esophageal dilatation and the anatomy location of the procedure was esophagus.It was reported that inflation was successful, however, the gauge reading was inaccurate.The procedure was completed with another alliance ii inflation syringe with different lot number.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20887597
• Report Number: 3005099803-2024-06210
• Device Sequence Number: 12742951
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: 08714729746737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/30/2024

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: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0034697605
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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