MAUDE Adverse Event Report: BIOSENSE WEBSTER 10 FRENCH SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Lot Number	2231837
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ice soundstar equipment used during case had blood on the part handed off to be plugged into our ultrasound machine.Unsure if the blood was on there when item was opened or this was from the current patient.Staff did not come in contact with this.Was seen by rep here for our equipment for ep ablations.Biosense webster, irvine, ca 92618 us.

• Brand Name: BIOSENSE WEBSTER 10 FRENCH SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• MDR Report Key: 21854089
• Report Number: MW5169244
• Device Sequence Number: 20014040
• Product Code: OWQ
• UDI-Device Identifier: 10888551014458
• UDI-Public: (01)10888551014458
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/14/2025

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: 02/24/2026
• Device Lot Number: 2231837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown