MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO 8FG ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation with a soundstar eco 8fg ultrasound catheter and the patient experienced thrombosis that caused case cancellation.The physician tried to do left atrium (la) mapping with a soundstar eco 8fg ultrasound catheter, but the procedure was stopped because left atrial appendage (laa) thrombus was seen on the echo image.The procedure was not completed successfully.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: SOUNDSTAR ECO 8FG ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive; suite 200; irvine CA 92618
• MDR Report Key: 19354726
• Report Number: 3023245-2024-00027
• Device Sequence Number: 7678044
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Catalogue Number: 10439011
• Device Lot Number: E8504274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2024