MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AVVIGO?+; computer, diagnostic, programmable

Model Number	H7492493120I0
Medical Device Problem Codes	Nonstandard Device (1420); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An avvigo multi-modality guidance system was selected for use.During the case the system would not "go live".The procedure was canceled.
Additional Manufacturer Narrative
D2b, pro code (product code), dsk, itx, iyo.
Additional Manufacturer Narrative
D2b, pro code (product code), dsk, itx, iyo.
Event or Problem Description
It was reported that the procedure was cancelled.An avvigo multi-modality guidance system was selected for use.During the case the system would not "go live".The procedure was canceled.

• Brand Name: AVVIGO?+
• Common Device Name: computer, diagnostic, programmable
• 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 -579
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 24254519
• Report Number: 2124215-2026-06246
• Device Sequence Number: 18224461
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K230884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2026

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: H7492493120I0
• Device Catalogue Number: H7492493120I0
• Device Lot Number: 0104728136
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 07/21/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/18/2026; 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown