MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; INTRAVASCULAR ULTRASOUND CATHETER

Catalog Number	10135910
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
It was reported by the caller, clinical account specialist that the acuson acunav¿ ultrasound catheter was connected and the image did not display on the ultrasound system.The caller noted that the swiftlink was not recognized by the ultrasound system when it was connected to the catheter.The catheter was reseated without resolution.The catheter was replaced without resolution.The ultrasound system and catheter were both replaced with a "st jude's," and the issue was resolved.The procedure continued.The caller requested two replacement catheters.The caller stated that both catheters are not available for return.Procedure: tips the caller noted that the carto¿ 3 system was not used the caller noted that no ablation generator was used.The caller was advised to contact ge customer service regarding the ultrasound system.Documentation approved by css (b)(6).

• Common Device Name: INTRAVASCULAR ULTRASOUND CATHETER
• 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: 24376622
• Report Number: 3023245-2026-00009
• Device Sequence Number: 20068975
• Product Code: OBJ
• UDI-Device Identifier: 04056869001043
• UDI-Public: 04056869001043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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
• Device Catalogue Number: 10135910
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown