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

Catalog Number	10439236
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
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 ref.# (b)(4).
Event or Problem Description
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar catheter which had the deflection mechanism "stuck." the caller replaced the soundstar® catheter and the issue was resolved.The procedure was able to continue without any further issues.There was no patient consequence.
Additional Manufacturer Narrative
On 5-dec-2025, the date of manufacture was received.Field h4.Device manufacture date has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
Correction: on 8-dec-2025, it was noticed the bwi product analysis lab received the complaint device for evaluation.The information was inadvertently omitted from the 3500a supplemental (follow-up) # 1.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar catheter which had the deflection mechanism "stuck." device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and deflection test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.A deflection test was performed, and the device was deflecting within specifications.No deflection issues were observed.The deflection knobs were evaluated and no issues were observed; the knobs were within specification.A device history record review was performed, and no internal actions related to the complaint were found during the review.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.The instructions for use (ifu) contain the following information: rotate the steering knobs.The steering function should be smooth.The catheter tip should flex in a corresponding direction.As part of johnson and 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 ref.# (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: 23723508
• Report Number: 2029046-2025-04010
• Device Sequence Number: 10650167
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)260917
• 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,Followup,Followup

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: 09/17/2026
• Device Catalogue Number: 10439236
• Device Lot Number: G9527573
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 12/08/2025; 12/17/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/12/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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: CARTO 3 SYSTEM.; TRUPULSE GENERATOR, US.
• Patient Sex: Unknown