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

Catalog Number	10439236
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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 (afib) ablation procedure and the locking mechanism for the soundstar catheter got stuck and would not unlock.The soundstar catheter was replaced, and the issue was resolved.Procedure continued.No adverse patient consequence was reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and the locking mechanism for the soundstar catheter got stuck and would not unlock.The soundstar catheter was replaced, and the issue was resolved.Procedure continued.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection and deflection test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The curve deflected within specifications.The locking mechanism can be locked and unlocked without any issue.A device history record evaluation was performed for the finished device number g9427281, and no internal action was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The deflection 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 instruction for use (ifu) contains the following warnings: rotate the steering knobs.The steering function should be smooth.The catheter tip should flex in a corresponding direction.If the soundstar® catheter tip does not return to the neutral position after you release the steering knobs, ensure that the tension control knob is completely released.Release the tension by rotating the tension control knob completely in a counterclockwise direction.Position the steering knobs in the neutral position by aligning the marks on the steering knobs to the marks on the housing.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).
Additional Manufacturer Narrative
Per internal review on 10-mar-2025, it was identified that the h6 medical device problem code was updated from mechanical jam (a0506) to positioning problem (a1502).Due to event referring to the locking mechanism, with no mention of the curve status, it was determined that the code of positioning problem (a1502) is most applicable.As such, this event is no longer considered to be a mdr reportable event.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21049055
• Report Number: 2029046-2024-04187
• Device Sequence Number: 3409178
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)250909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 09/09/2025
• Device Catalogue Number: 10439236
• Device Lot Number: G9427281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/10/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/12/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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: NGEN SYSTEM.
• Patient Sex: Unknown