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

Catalog Number	10439236
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 cardiac ablation procedure with a soundstar catheter and when the physician took the soundstar catheter out of the box, and started to use it by inserting to patient, he noticed something white that was on the tip of catheter.The size was very small, and it was like a white dot.The physician thought that this one is contaminated and requested to change it with new one to continue with the procedure safely.The device was not used on the patient and there was no adverse patient consequence reported.
Additional Manufacturer Narrative
Correction to the initial report.The correct lot number for this event has been identified as g9369817.Therefore, d 4.Lot and d 4.Primary udi number have been updated.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 white foreign material was found during the analysis.The picture provided by the customer could not provide additional information.A device history record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The foreign material 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 catheter instructions for use (ifu) contain the following recommendations: inspect the sterile package prior to catheter use.Do not use the soundstar® catheter if the packaging is open or damaged.In this case, contact your local representative.Using a soundstar® catheter that has been stored in an open or damaged package can result in patient injury.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
The device investigation was corrected on 27-dec-2024 as follows: 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 white foreign material was found during the analysis, and the particle was not returned for further analysis; however, according to the picture provided by the customer, a white material was observed on the tip of the device.A device history record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The foreign material reported by the customer was confirmed.Since the white particle or the packaging of the device were not properly returned for further analysis, the potential cause of the foreign material could not be determined.The catheter instructions for use (ifu) contain the following recommendations: inspect the sterile package prior to catheter use.Do not use the soundstar® catheter if the packaging is open or damaged.In this case, contact your local representative.Using a soundstar® catheter that has been stored in an open or damaged package can result in patient injury.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Additional coding of tip (g04129) has been added to h 6.Component code.Additional coding of analysis of data provided by user/third party (b15) has been added to h 6.Type of investigation.Correction to h 6.Investigation conclusions: code of passed specs (d14) has been replaced with cause not established (d15).Correction to h 6.Investigation findings: code of no device problem found (c19) has been replaced with inappropriate material (c0602).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: 19813052
• Report Number: 2029046-2024-02477
• Device Sequence Number: 8665338
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)250128(10)G9369817
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: 01/28/2025
• Device Catalogue Number: 10439236
• Device Lot Number: G9369817
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 12/27/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/12/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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
• Patient Sex: Unknown