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

Model Number	H7492493120I0
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the opticross catheter was misrecognized.An opticross 6hd and avvigo plus system were selected for ultrasound examination of the target lesion.During the procedure, the opticross 6hd was being identified as an opticross 18 while it was plugged in to the avvigo plus mdu.This resulted in the images not being to scale.There were no patient complications.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20789547
• Report Number: 2124215-2024-74775
• Device Sequence Number: 6833765
• Product Code: DQK
• UDI-Device Identifier: 00191506033163
• UDI-Public: 00191506033163
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/26/2024

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: 0104733857
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown