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	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used in the papilla during an endoscopic papillary balloon dilation procedure performed on (b)(6) 2024.During the procedure, the alliance ii syringe was connected to the device and dilation was performed but, the pressure measurement on the gauge was not correct.Fluoroscopy indicated that the pressure had increased, and the balloon was inflated.The syringe was removed, and a second alliance ii inflation syringe was attempted to be used but, again the pressure measurement on the gauge was not correct.The procedure was completed with the second alliance ii inflation syringe only by confirmation under fluoroscopy.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 inaccurately.Block h11: investigation results the returned alliance ii inflation syringe was analyzed, and a visual evaluation noted no damages.Functional testing was performed and found the pressure gauge needle not increasing.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of gauge reading inaccuracy was confirmed.The returned device was inspected, and functional testing found the pressure gauge needle not increasing.The way in which the device was handled and manipulated, such as a possible hit on the gauge or an accidental drop of the device, may have caused the failure.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that an alliance ii inflation syringe was attempted to be used in the papilla during an endoscopic papillary balloon dilation procedure performed on (b)(6) 2024.During the procedure, the alliance ii syringe was connected to the device and dilation was performed but, the pressure measurement on the gauge was not correct.Fluoroscopy indicated that the pressure had increased, and the balloon was inflated.The syringe was removed, and a second alliance ii inflation syringe was attempted to be used but, again the pressure measurement on the gauge was not correct.The procedure was completed with the second alliance ii inflation syringe only by confirmation under fluoroscopy.There were no patient complications reported 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20717231
• Report Number: 3005099803-2024-05882
• Device Sequence Number: 8334188
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: 08714729129332
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 06/13/2026
• Device Model Number: M00550601
• Device Catalogue Number: 5060-05
• Device Lot Number: 0034233549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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