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

Catalog Number	SNDSTR10G
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and soundstar magnetic, transducer, recognition, and visualization test were performed.The visual inspection revealed that shaft was torn with internal parts exposed on the device.It was connected to both the carto 3 system and the acuson system, and device was not recognized and no image was displayed.A transducer test was unable to be performed due to shaft's condition.Additionally, a microscopic inspection was performed, and delamination was observed during microscopic inspection.This could be related to a poor image issue.A device history record evaluation was performed for the finished device batch number, and no internal actions were identified.The poor image issue reported by the customer was confirmed as delamination was detected.The potential cause of the delamination could not be determined.The damage in the shaft was not reported by the customer; however, it could be related to the issue reported.The potential cause could be related to the manipulation of the device during or after the procedure; however, this cannot be conclusively determined.The carto 3 system instructions for use (ifu) contain the following information: connections for video signal between vivid i/q and the carto ® 3 system must be made only through the isolated video splitter supplied by either ge or biosense webster.Use of any other splitter might cause degraded quality of the ultrasound images displayed by the carto ® 3 system.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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 a cardiac ablation procedure with a soundstar catheter and during the operation, the acoustic image of the ultrasound system had poor quality or there were issues with the video.A second device was used to complete the operation.There was no adverse event reported on the patient.This event was originally assessed as not mdr reportable.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and soundstar magnetic, transducer, recognition, and visualization test were performed.The visual inspection revealed that the shaft was torn with internal parts exposed on the device.This finding is mdr reportable.

• 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: 24424095
• Report Number: 2029046-2026-00623
• Device Sequence Number: 5939540
• Product Code: OBJ
• UDI-Device Identifier: 10846835000153
• UDI-Public: 10846835000153
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 06/25/2026
• Device Catalogue Number: SNDSTR10G
• Device Lot Number: G3127915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/23/2026
• 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
• Patient Sex: Unknown