MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR; 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	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a soundstar catheter.The soundstar catheter had plastic material attached to the handle in multiple locations where it should not be, right out of the package.The catheter was replaced and the procedure continued.No patient consequence.Additional information was received.The issue was noticed before use on the patient.No picture available.Material observed was embedded to the device.Confirmed that the section of the catheter that the issue was found was the handle.No physical damage noted.Just the foreign material.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 12-dec-2025.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).
Additional Manufacturer Narrative
H4.Device manufacture date has been added.The device evaluation was completed on 16-jan-2026.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a soundstar catheter.The soundstar catheter had plastic material attached to the handle in multiple locations where it should not be, right out of the package.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection was performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.A device history review was performed for the finished device batch number, and no internal actions were identified.The foreign material issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.During the 3500a initial report under ¿h11.Additional manufacturer narrative¿ reported, ¿the bwi product analysis lab received the device for evaluation on 12-dec-2025.¿ however, in error, did not process the following fields.Therefore, processed: -d 9.Date device returned to manufacturer -d 9.Is device returned to manufacturer? -d 9.Device available for evaluation? 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
• 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: 23805188
• Report Number: 2029046-2025-04155
• Device Sequence Number: 18069428
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(11)260924
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 09/24/2026
• Device Catalogue Number: 10439236
• Device Lot Number: G9529598
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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: FARAPULSE GENERATOR.; UNK_CARTO 3.
• Patient Sex: Unknown