MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AVVIGO GUIDANCE SYSTEM II; COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE

Model Number	2425-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was aborted.The avvigo guidance system ii was selected for use.During the procedure, an error occurred, and system failed to start up.The procedure was not completed due to this event and was rescheduled.
Additional Manufacturer Narrative
The acquisition pc was returned for analysis.Visual inspection revealed no issues.Device to device testing failed.The device was unable to boot to the application and failed startup.An error code was displayed confirming the allegation.Functional testing could not be performed due to the error and limited software testing capabilities.A malware scan revealed no issues.Factory level testing showed no hardware problems with the acquisition pc.
Event or Problem Description
It was reported that a procedure was aborted.The avvigo guidance system ii was selected for use.During the procedure, an error occurred, and system failed to start up.The procedure was not completed due to this event and was rescheduled.

• Brand Name: AVVIGO GUIDANCE SYSTEM II
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19411556
• Report Number: 2124215-2024-32106
• Device Sequence Number: 19636578
• Product Code: DQK
• UDI-Device Identifier: 00191506015152
• UDI-Public: 00191506015152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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 Model Number: 2425-01
• Device Catalogue Number: 2425-01
• Device Lot Number: 0100026111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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