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

Catalog Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.An analysis of the product could not be performed since a physical sample was not received for evaluation.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 an atrial fibrillation ablation with a soundstar® eco diagnostic ultrasound catheter and the patient experienced pseudoaneurysm that required surgical intervention.After an atrial fibrillation case, a pseudoaneurysm was noticed.The scrub tech noticed the patient was bleeding from the access point.The physician inspected the access point and determined the injury was a pseudoaneurysm.The patient was being sent to surgery for medical intervention.The patient was reported to be in stable condition.The medical team believed the injury was a result of getting intracardiac echo (ice) catheter access in the vein.The physician believes they hit an artery instead of a vein while attempting to gain venous access.Physician thinks it was patient anatomy and nothing to do with bwi products.Other relevant medical history includes previous graft placed that may have been ruptured during access.

• Brand Name: SOUNDSTAR® ECO DIAGNOSTIC 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): SIEMENS LTD. SEOUL; venture bldg 2, office 112 601; pohang technopark, jigok-dong; gyeongbuk 790-8 34; KS 790-834
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21502022
• Report Number: 2029046-2025-00635
• Device Sequence Number: 8020446
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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 Catalogue Number: 10439072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PFA FARAPULSE SYSTEM.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown