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

Model Number	H7492493120I0
Medical Device Problem Codes	Incorrect Measurement (1383); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inaccurate measurement occurred.An avvigo plus multi-modality guidance system was selected.During the procedure, the minimal lumen area (mla) measurements were inaccurate.It was also noted that the fractional flow reserve (ffr) and diastolic hyperemia-free ratio (dfr) values were able to equalize but disappeared during pullback.The procedure was completed and there were no patient complications.
Additional Manufacturer Narrative
D2b: pro-code: dsk, itx, iyo.

• 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: 25116545
• Report Number: 2124215-2026-24887
• Device Sequence Number: 21162564
• Product Code: DQK
• UDI-Device Identifier: 00191506033163
• UDI-Public: (01)00191506033163(11)231002(10)102780107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: H7492493120I0
• Device Catalogue Number: H7492493120I0
• Device Lot Number: 0102780107
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown