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

Model Number	H7492493120C0
Medical Device Problem Codes	Nonstandard Device (1420); Device Displays Incorrect Message (2591); Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system misidentified the imaging catheter.An avvigo plus imaging system was selected for examination of the target lesion.Prior to the procedure, it was noted that the motor drive unit was misreading catheters, and the catheters were not able to completely lock in.Despite the issue, the avvigo plus system was still used to make treatment decisions.The procedure was able to be completed successfully, and there were no patient complications.
Additional Manufacturer Narrative
D2b additional pro codes: dsk, itx, iyo.
Event or Problem Description
It was reported that the system misidentified the imaging catheter.An avvigo plus imaging system was selected for examination of the target lesion.Prior to the procedure, it was noted that the motor drive unit was misreading catheters, and the catheters were not able to completely lock in.Despite the issue, the avvigo plus system was still used to make treatment decisions.The procedure was able to be completed successfully, and there were no patient complications.
Additional Manufacturer Narrative
D2b additional pro codes: dsk, itx, iyo.The returned product consisted of the motor drive unit (mdu).A visual inspection revealed corrosion on the rotating direct connection socket pins.Testing the mdu with a catheter did not cause any issues.The device malfunction could not be duplicated during functional testing.This investigation is assigned a conclusion code of no problem detected.

• 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: 22203758
• Report Number: 2124215-2025-38394
• Device Sequence Number: 6755341
• Product Code: DQK
• UDI-Device Identifier: 00191506033125
• UDI-Public: (01)00191506033125(11)250312(10)107864411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 11/14/2025

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: 0107864411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown