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

Model Number	M00550601
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a020503 captures the reportable event of device packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was unpacked on (b)(6) 2025.It was reported that the sealing sticker has been peeled off.No further information has been obtained despite good faith efforts.The reported event may suggest that the sterile barrier was compromised.The device was never in service and there were no patients involved in this event.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was unpacked on (b)(6) 2025.It was reported that the sealing sticker has been peeled off.No further information has been obtained despite good faith efforts.The reported event may suggest that the sterile barrier was compromised.The device was never in service and there were no patients involved in this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of device packaging seal compromised.Block h11: the returned alliance ii inflation syringe was analyzed, visual inspection found that the box was returned with evidence of sticker damaged.The devices inside the box showed no evidence of damage.No other problems with were noted.With all the available information, boston scientific concludes the reported event of packaging seal compromised was confirmed.The problem found could be caused due to environmental factors during the transport or storage of the device, also an incorrect storage of the box, without the proper conditions could have induced the analyzed defects.Therefore, the most probable root cause is cause traced to transport/storage.

• 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 ; 9145716918
• MDR Report Key: 23350282
• Report Number: 3005099803-2025-05461
• Device Sequence Number: 20822489
• Product Code: MAV
• UDI-Device Identifier: 08714729129332
• UDI-Public: (01)08714729129332(17)270718(10)37000992
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 5060-05
• Device Lot Number: 0037000992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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