MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR 3D 10F-90; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	SNDSTR10
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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 - paroxysmal ablation procedure with a soundstar catheter and the medical team discovered that after the knob is rotated, it cannot automatically return to the initial position.The curve was not straightening by itself.Even through manual manipulation, the medical team found that it was impossible to return the curve to its neutral position.No further details were provided regarding troubleshooting of the issue or completion of the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
On 3-jun-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a soundstar catheter and the medical team discovered that after the knob is rotated, it cannot automatically return to the initial position.The curve was not straightening by itself.Even through manual manipulation, the medical team found that it was impossible to return the curve to its neutral position.No further details were provided regarding troubleshooting of the issue or completion of the procedure.No patient consequences were reported.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and deflection test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that the puller wire of the device was observed broken in the handle area, no other damage or anomalies were observed.Deflection testing was performed, and the deflection mechanism curves failed due to the puller wire being broken in the handle.This condition could be related to the issue described by the customer.A device history record evaluation was performed for the finished device s1525349, and no internal action was found during the review.The issue reported by the customer was confirmed.The potential cause of the puller wire broken could not be established conclusively.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech's 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 3D 10F-90
• 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: 22110892
• Report Number: 2029046-2025-01750
• Device Sequence Number: 7062551
• Product Code: OBJ
• UDI-Device Identifier: 10846835000139
• UDI-Public: (01)10846835000139(17)260508(10)S1525349
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070242
• 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): 06/25/2025

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: 05/08/2026
• Device Catalogue Number: SNDSTR10
• Device Lot Number: S1525349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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
• Patient Sex: Unknown