MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV G 10F-90 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10043342
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
During an unknown procedure, no image was displayed when the catheter was connected.Surgery was delayed by 10 minutes.The procedure was successfully completed with no patient impact.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide investigation information.The returned catheter was inspected and during the investigation it was found that the root cause of this issue was incomplete insertion of the interconnect tab to the swiftlink connector.This is a case of user mishandling.Reference# (b)(4).

• Brand Name: ACUNAV G 10F-90 CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; 6506257209
• MDR Report Key: 24284759
• Report Number: 3023245-2026-00004
• Device Sequence Number: 9962782
• Product Code: OBJ
• UDI-Device Identifier: 04056869001036
• UDI-Public: 04056869001036
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 10043342
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown