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

Catalog Number	10439072
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 ablation procedure with a soundstar catheter with when the catheter was about to be opened the medical team saw that the packaging was compromised with a cut in it.They opened another catheter and the case continued.No patient consequences were reported.
Additional Manufacturer Narrative
On 7-feb-2026, the product investigation was completed.Additionally, internal review on 3-mar-2026, identified that the bwi product analysis lab received the device for evaluation and that product receipt was mistakenly omitted from the initial report, and section d11 has been updated with the receipt date of 19-jan-2026.It was reported that a patient underwent an atrial fibrillation ablation procedure with a soundstar catheter with when the catheter was about to be opened the medical team saw that the packaging was compromised with a cut in it.They opened another catheter and the case continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual inspection revealed no damage or anomalies on the device.No original packaging was returned to analysis site; therefore, no further analysis could be performed.A device history record evaluation was performed for the finished device lot number g4190620 and no internal action was found during the review.The packaging issue reported by the customer could not be replicated during the product investigation due to no packaging was returned to analysis site.The instructions for use (ifu) contain the following information: do not use if package is opened.Do not use if package is damaged.As part of johnson & 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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24152482
• Report Number: 2029046-2026-00290
• Device Sequence Number: 10658475
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: (01)10846835008845(17)261103(10)G4190620
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: 10439072
• Device Lot Number: G4190620
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/07/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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
• Patient Sex: Unknown