MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO GE 10F CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial flutter ablation with a soundstar eco ge 10f catheter and the patient experienced thrombus, cardiac failure, and cardiac arrest that required cpr.It was reported that the patient had a "sluggish" ejection fraction when soundstar catheter was placed in the patient.The patient went into pea (pulseless electrical activity) shortly after the catheter was used to visualize the heart.A code was called and cpr was initiated.It was also reported that a clot was visualized in the right atrium.The patient was stable and no further intervention was planned.Patient was transferred to icu.The physician's opinion on the cause of the adverse event was patient condition.No ablation catheter was opened and no ablation was done.The soundstar was in the patient.No transseptal puncture was done and it was still right sided.No error messages observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
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
On 12-dec-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial flutter ablation with a soundstar eco ge 10f catheter and the patient experienced thrombus, cardiac failure, and cardiac arrest that required cpr.It was reported that the patient had a "sluggish" ejection fraction when soundstar catheter was placed in the patient.The patient went into pea (pulseless electrical activity) shortly after the catheter was used to visualize the heart.A code was called and cpr was initiated.It was also reported that a clot was visualized in the right atrium.The patient was stable and no further intervention was planned.Patient was transferred to icu.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and revision of all features were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A device history review was performed for the finished device number lot g4139822 and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 GE 10F 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: 20861402
• Report Number: 2029046-2024-03913
• Device Sequence Number: 14467770
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: (01)10846835008845(17)250616(10)G4139822
• 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,Followup
• Report Date (Section B): 01/08/2025

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 Expiration Date: 06/16/2025
• Device Catalogue Number: 10439072
• Device Lot Number: G4139822
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American