MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10439072
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event 1 [date redacted] lot: g4173172.During prep of the ultrasound catheter, the was an error message.The catheter was removed and replaced with no harm to the patient.Event 2 [date redacted] lot: g4175334.There was a defective connector on the ultrasound catheter.The catheter was removed and replaced with no harm to the patient.Manufacturer response for ultrasound catheter, 10fr x 90cm soundstar eco diagnostic ultrasound catheter (per site reporter).Mfg [manufacturer] notified by site.

• Brand Name: SOUNDSTAR
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive; suite 200; irvine CA 92618
• MDR Report Key: 22622810
• Report Number: 22622810
• Device Sequence Number: 20939776
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: (01)10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

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
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4173172, G4175334
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/10/2025