MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AVVIGO?+; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H7492493120C0
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b, pro code (product code), dsk, itx, iyo.
Event or Problem Description
It was reported that the procedure was cancelled.During the procedure, an avvigo multi-modality guidance system was selected for use, the image showed up was affected by a snowflake-like artifact.The procedure was cancelled due to the issue prior to treatment being completed.

• 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 5798
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24570726
• Report Number: 2124215-2026-13603
• Device Sequence Number: 12853531
• Product Code: DQK
• UDI-Device Identifier: 00191506033125
• UDI-Public: (01)00191506033125(11)250417(10)108284591
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K230884
• 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
• Report Date (Section B): 03/11/2026

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: H7492493120C0
• Device Catalogue Number: H7492493120C0
• Device Lot Number: 0108284591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown