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

Catalog Number	10135936
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	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The arrhythmia specialist informed in that in a cryoballoon ablation the day prior, the acunav catheter was opened.It was connected to the siemens p500 ultrasound machine in the normal fashion.When trying to select the catheter as a transducer, the option was not available.The catheter connection sequence was redone; however, the ultrasound system was still not recognizing the catheter.The ultrasound system was restarted and the catheter was connected to the swiftlink.The catheter was still not being recognized by the ultrasound system.An abbott viewflex was opened instead using the viewmate ultrasound machine.The case continued without further issues.Was surgery delayed due to the reported event? yes, if yes, number of minutes: 15, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.- true.

• 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: 24376627
• Report Number: 3023245-2026-00007
• Device Sequence Number: 14687836
• Product Code: OBJ
• UDI-Device Identifier: 04056869001029
• UDI-Public: 04056869001029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 10135936
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown