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

Catalog Number	10043342
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	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the caller, clinical account specialist that after the acuson acunav¿ ultrasound catheter was connected to the "ge" ultrasound system, the catheter was not recognized by the system.The swiflink connecter was reseated without resolution.The ultrasound system was restarted without resolution.The catheter was replaced without resolution.The swiftlink connector was replaced, and the issue persisted.The caller stated that the ultrasound system and catheter were both replaced with another (vue flex catheter) and the issue resolved.The procedure continued with no further issues.The caller is requesting two replacement catheters.The caller stated that the acuson acunav¿ ultrasound catheters are available for return.Return kit requested.The caller noted that the carto¿ 3 system was not used.The caller noted that the medtronic affera was used.Documentation approved by css ws.

• 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: 24376638
• Report Number: 3023245-2026-00011
• Device Sequence Number: 4942062
• Product Code: OBJ
• UDI-Device Identifier: 04056869001036
• UDI-Public: 04056869001036
• 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: 10043342
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown