MAUDE Adverse Event Report: Biosense Webster Inc NUVISION Ultrasound Catheter; Catheter, Ultrasound, Intravascular

Catalog Number	FG12080
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction

• Brand Name: NUVISION Ultrasound Catheter
• Common Device Name: Catheter, Ultrasound, Intravascular
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Biosense Webster Inc (Juarez); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50512286
• Report Number: 3013300026-2026-02842
• Device Sequence Number: 21503043
• Product Code: OBJ
• UDI-Device Identifier: 10846835026566
• UDI-Public: (01)10846835026566(17)260922(10)31757386L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial

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 Expiration Date: 09/22/2026
• Device Catalogue Number: FG12080
• Device Lot Number: 31757386L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown