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

Model Number	M00550600
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a020504 captures the reportable event of tear, rip or hole in device packaging.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use on a procedure performed on (b)(6) 2025.During preparation, the tape (seal) was torn.The product was not used in any procedure.The patient was not present at the time of the event and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of tear, rip or hole in device packaging.Block h11: investigation results- the returned alliance ii inflation syringe was analyzed, and a visual evaluation found the device with the box had several damages and the seal was ripped.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of packaging tear, rip or hole in device packaging was confirmed.The returned device with the box had several damages and the seal was ripped.These issues could be caused due to environmental factors during the transport or storage of the device, also incorrect storage of the box, without the proper conditions could have induced the issues.Therefore, the most probable root cause is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that an alliance ii inflation syringe was being prepared for use on a procedure performed on (b)(6) 2025.During preparation, the tape (seal) was torn.The product was not used in any procedure.The patient was not present at the time of the event and 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21758572
• Report Number: 3005099803-2025-01385
• Device Sequence Number: 8758810
• Product Code: MAV
• UDI-Device Identifier: 08714729746737
• UDI-Public: (01)08714729746737(17)270102(10)35541491
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Model Number: M00550600
• Device Catalogue Number: 5060-05S
• Device Lot Number: 0035541491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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