MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETE; 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	05/18/2025
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 - paroxysmal ablation procedure with a soundstar® eco diagnostic ultrasound catheter and after the knob was rotated, it could not be automatically return to the initial position and needed to be corrected manually.However, the medical team then confirmed that they were unable to manually rotated the deflecting knobs at all.The curve would also refuse to straighten itself when releasing the locking mechanism.No further details were provided regarding troubleshooting of the device or completion of the procedure.No patient consequences were reported.
Additional Manufacturer Narrative
On 2-jul-2025, 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).
Additional Manufacturer Narrative
On 03-oct-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation - paroxysmal ablation procedure with a soundstar® eco diagnostic ultrasound catheter and after the knob was rotated, it could not be automatically return to the initial position and needed to be corrected manually.However, the medical team then confirmed that they were unable to manually rotated the deflecting knobs at all.The curve would also refuse to straighten itself when releasing the locking mechanism.No further details were provided regarding troubleshooting of the device or completion of the procedure.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 and deflection test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.A deflection test was performed, and the device was deflecting within specifications; when the curve was unlocked the curve would not go back to neutral position automatically, but it could be released by manually adjusting the deflection knob; however, the locking knob required additional force to operate, but the functionality was confirmed to be normal.For this reason, the device was dissected and inspected, and stress marks were observed on the neoprene washer.Dimensional measurement was performed, and the washer was thicker than usual but remained within defined manufacturing specifications at the time.A device history record evaluation was performed for the finished device number (b)(6), and no internal actions related to the reported condition were identified.The deflection issue reported by the customer was confirmed.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.As part of the 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® ECO DIAGNOSTIC ULTRASOUND CATHETE
• 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: 22186531
• Report Number: 2029046-2025-01898
• Device Sequence Number: 15600548
• Product Code: OBJ
• UDI-Device Identifier: 10846835000139
• UDI-Public: (01)10846835000139(17)260123(10)S1547303
• 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,Followup
• Report Date (Section B): 10/22/2025

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: 01/23/2026
• Device Catalogue Number: SNDSTR10
• Device Lot Number: S1547303
• 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: 05/18/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 10/03/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/28/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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