MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO GE 10F CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439072
Medical Device Problem Codes	Communication or Transmission Problem (2896); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a soundstar catheter and the catheter was not recognized by the s70 ultrasound system when it was connected to the piu on the carto 3 system.Changing out the ultrasound system and the swiftlink cable did not resolve the issue.Connecting a dummy catheter resolved the issue.They then replaced the soundstar catheter and the issue was resolved, and the procedure was then continued.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, recognition, and visualization testing of the returned device were performed.Visual analysis of the returned device revealed two cuts on the shaft and internal components exposed.This finding is mdr reportable.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and soundstar magnetic, recognition, and visualization testing of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed two cuts on the shaft and internal components exposed, additionally the shaft was bent.A soundstar magnetic, recognition, and visualization testing was performed, and the device failed as error 6150 appeared on the system due to an internal printed circuit board (pcb) issue.Resistance values at the connector area were verified and found within specifications.The pcb area was visually inspected, and no anomalies were found.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The potential cause of the pcb issue could not be established conclusively.The potential cause of the bent and cut shaft could be related to the handling/shipping of the device after the procedure; however, this could not be conclusively determined.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).

• Brand Name: SOUNDSTAR ECO GE 10F CATHETER
• 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: 24096663
• Report Number: 2029046-2026-00218
• Device Sequence Number: 10209840
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: (01)10846835008845(17)260903(10)G4186631
• 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
• Report Date (Section B): 01/16/2026

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: 09/03/2026
• Device Catalogue Number: 10439072
• Device Lot Number: G4186631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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: SOUNDSTAR ECO GE 10F CATHETER.; SOUNDSTAR ECO GE 10F CATHETER.; SWIFTLINK CABLE.; THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Patient Sex: Unknown