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

Model Number	H7492493120C0
Medical Device Problem Codes	Poor Quality Image (1408); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).D2b pro codes continued: 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 procedure, the equipment showed a distorted image with artifacts making analysis of the artery impossible.There were no patient complications reported.

• 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: 23694763
• Report Number: 2124215-2025-86244
• Device Sequence Number: 9193668
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/11/2026

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: 0108267647
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 06/11/2026
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown