MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALLIANCE II; SYRINGE, BALLOON INFLATION

Model Number	M00550620
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0902 captures the reportable event of reading inaccurate.
Event or Problem Description
Note: this report pertains to one of two alliance ii inflation/litho devices used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation/litho devices were used during a dilatation procedure performed on an unknown date.During the procedure, the pressure does not go up when the pressure is increased but goes down immediately.The same problem occurred with the second alliance ii inflation/litho device.The procedure was completed with another alliance ii inflation/litho device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.Block h11 (correction): block b5 (describe event or problem), block d2, d4 (suspected medical device), block g1 (manufacturing site), h4 (device manufacture date) have been updated.
Event or Problem Description
Note: this report pertains to one of two alliance ii inflation/litho devices used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation/litho devices were used during a dilatation procedure performed on an unknown date.During the procedure, the pressure does not go up when the pressure is increased but goes down immediately.The same problem occurred with the second alliance ii inflation/litho device.The procedure was completed with another alliance ii inflation/litho device.There were no patient complications reported as a result of this event.***correction noted on december 20, 2023*** the device type was corrected from an alliance ii handle inflation device to an alliance ii inflation syringe.

• 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 MA T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17733637
• Report Number: 3005099803-2023-04887
• Device Sequence Number: 5820263
• Product Code: MAV
• UDI-Device Identifier: 08714729283881
• UDI-Public: 08714729283881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K860589
• 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): 01/12/2024
• 2 Devices were Involved in the Event: 1 2

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: M00550620
• Device Catalogue Number: 5062
• Device Lot Number: 0005191538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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