MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO SMS 10F CATHETER; 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	10/09/2024
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 a supraventricular tachycardia ablation procedure with a soundstar eco sms 10f catheter and after the physician activated the deflection it would not go back to neutral.The catheter was removed from the body but remained in the deflected position.The knobs were in neutral and it was not locked.There was no difficulty in removing the catheter; however, the medical team found the turning of the knobs to be stiff.The catheter was replaced and the procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
On 12-nov-2024, the product investigation was completed.Additionally, it was identified that the product receipt of 30-oct-2024 was mistakenly omitted from the previous 3500a initial report and has been included in this supplemental.It was reported that a patient underwent a supraventricular tachycardia ablation procedure with a soundstar eco sms 10f catheter and after the physician activated the deflection it would not go back to neutral.The catheter was removed from the body but remained in the deflected position.The knobs were in neutral and it was not locked.There was no difficulty in removing the catheter; however, the medical team found the turning of the knobs to be stiff.The catheter was replaced and the procedure 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 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.No deflection issues were observed.A device history review was performed for the finished device number lot e5195730 and no internal action related to the complaint was found during the review.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the use of the device that may have affected its performance.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 johnson and johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product complaint will be addressed through the quality system.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 SMS 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20571283
• Report Number: 2029046-2024-03519
• Device Sequence Number: 8575393
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: (01)10846835008838(17)250802(10)E5195730
• 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): 12/06/2024

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: 08/02/2025
• Device Catalogue Number: 10438577
• Device Lot Number: E5195730
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2024
• 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: CARTO 3 SYSTEM; NGEN GENERATOR; TX ECO CABLE
• Patient Sex: Unknown