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
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.
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).
Additional Manufacturer Narrative
The investigation was completed on (b)(6) 2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot e8504274 and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 30-jul-2024 correcting the lot number from e8504274 to e8504279.Therefore, updated the following: -d4.Lot.-d4.Expiration date.-d4.Primary udi number.The bwi product analysis lab received the device for evaluation 31-jul-2024.The device evaluation was completed on 14-aug-2024.Device evaluation summary: 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 product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed corrosion in the connector area.The resistance of the pins were measured and they were within specifications.No issues were observed.A device history review was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The potential cause of corrosion could not be determined since the device does not have an irrigation tube.The corrosion issue observed is not related to the adverse event reported by the customer.The potential cause of the adverse event remains unknown.In addition, no error messages were observed on biosense webster equipment during the procedure.The instruction for use (ifu) contains the following recommendations: careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade; do not immerse the swiftlink connector in fluid of any kind.If the swiftlink connector is immersed in or covered with fluid, contact your biosense webster representative.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: connector pin (g0403401) was selected as related to the biosense webster inc.Analysis finding of the ¿corrosion in the connector area¿.-investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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
• 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: 19343208
• Report Number: 2029046-2024-01612
• Device Sequence Number: 7340211
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: (01)10846835008852(17)240912(10)E8504279
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 09/12/2024
• Device Catalogue Number: 10439011
• Device Lot Number: E8504279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 07/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/01/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown