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

Catalog Number	10439236
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 procedure with a soundstar eco ge 8f catheter and there was adherent material on the tip of the catheter (something like a film).The material was identified when the sterile packaging of the was opened.The device was not inserted into the patient.Adherent material was loose, and it was possible to wipe it off with a moistened gauze, but the nature of the adherent material was unknown.The procedure was continued with catheter replacement (and the adherent material was discarded along with the gauze).The procedure was completed without patient's consequence.
Additional Manufacturer Narrative
On 1-sep-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a soundstar eco ge 8f catheter and there was adherent material on the tip of the catheter (something like a film).The material was identified when the sterile packaging of the was opened.The device was not inserted into the patient.Adherent material was loose, and it was possible to wipe it off with a moistened gauze, but the nature of the adherent material was unknown.The procedure was continued with catheter replacement (and the adherent material was discarded along with the gauze).The procedure was completed without patient's consequence.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech's procedures, a visual inspection was performed.Visual analysis revealed no damage or anomalies on the device.It was returned without its original packaging.A device history record evaluation was performed for the finished device number g9491919, and no internal actions related to the reported condition were identified.The foreign material reported by the customer could not be confirmed during the analysis.Other circumstances may have affected device performance.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product complaint will be addressed through the quality system.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 8F 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22901751
• Report Number: 2029046-2025-02873
• Device Sequence Number: 8814005
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)260528(10)G9491919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Catalogue Number: 10439236
• Device Lot Number: G9491919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NGEN¿ SYSTEM.; QDOT MICRO, BI, TC, D-F.
• Patient Sex: Unknown