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

Catalog Number	10438577
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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 reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and after the catheter was deflected and locked into position, the catheter would not unlock.It was removed without incident, and it was replaced.The case was continued without further incidence.No adverse patient consequence was reported.
Additional Manufacturer Narrative
The device evaluation was completed on 08-oct-2025.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and after the catheter was deflected and locked into position, the catheter would not unlock.It was removed without incident, and it was replaced.The case was continued without further incidence.No adverse patient consequence was reported.Device investigation details: the device was returned for evaluation.Visual inspection and deflection test of the returned device were performed following johnson & johnson medtech procedures.Visual analysis revealed several bents on the shaft of the device.A deflection test was performed, and the device was deflecting within specifications.The locking knob required additional force to operate; however, the functionality was confirmed to be normal.The device was dissected and inspected, and stress marks were observed on the neoprene washer.Dimensional measurement was performed on the washer, and it was thicker than usual but remained within defined manufacturing specifications at the time.A device history record evaluation was performed for the finished device lot number, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The deflection issue reported by the customer was confirmed as the stiffness on the locking knob could be related to the reported issue.The potential cause of the stiffness could be related to the thickness of the neoprene washer.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.The bent issue observed during the analysis is unrelated to the issue reported by the customer.The potential cause could be related to the handling of the device after the procedure; however, this cannot be conclusively determined.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: washer (g04138) were selected as related to the stress marks observed on the neoprene washer -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the several bents found on the shaft of the device -investigation findings: stiffness problem identified (c0705) / investigation conclusions: cause traced to manufacturing (d03) / component code: washer (g04138) were selected as related to the stiffness noted on the locking knob 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21601432
• Report Number: 2029046-2025-00779
• Device Sequence Number: 4527581
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: (01)10846835008838(17)251031(10)E5201168
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 10/31/2025
• Device Catalogue Number: 10438577
• Device Lot Number: E5201168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: FARAPULSE GENERATOR
• Patient Sex: Unknown