MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO 8F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439011
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.Visual inspection and soundstar magnetic, recognition, and visualization test were performed following bwi procedures.Visual analysis revealed that the shaft was broken in middle of the shaft.Soundstar magnetic, recognition, and visualization test was performed, and no issues were detected during the analysis.Device history record evaluation was performed for finished device number e8509995, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The root cause of the damage on the shaft could be related to the handling and/or shipping after the procedure; however, this cannot be conclusively determined.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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation - persistent ablation procedure with a soundstar eco 8f ultrasound catheter and post procedure the bwi product analysis lab identified a broken shaft (it was broken in the middle portion).During the procedure, once the soundstar eco 8f ultrasound catheter entered the heart a carto error 6150 (catheter sensor error) occurred.The soundstar catheter was unplugged and replugged in with fix to the error for approximately 30 seconds before the issue recurred.This was tried again with a short fix for another 30 seconds before error 6150 popped up again.A new soundstar eco dongle was tried with no fix to the error, but that didn't work either.A new soundstar catheter was used and the issue resolved.The overall surgical delay was approximately 6 minutes.The case continued on without any further issues.No patient consequences were reported.

• Brand Name: SOUNDSTAR ECO 8F ULTRASOUND 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: 19216190
• Report Number: 2029046-2024-01407
• Device Sequence Number: 18169179
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140318
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: 10/23/2024
• Device Catalogue Number: 10439011
• Device Lot Number: E8509995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: DECANAV CATHETER.; UNK CARTO SYSTEM.
• Patient Sex: Unknown