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

Catalog Number	SNDSTR10
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a soundstar catheter and the patient experienced delay in surgery which resulted in an increase risk to the patient.Visualization issue.Fourteen days ago, the patient was admitted to the hospital for surgery.When the three-dimensional diagnostic ultrasound catheter was used during the surgery, the screen showed no imaging.The doctor plugged and connected for several times and still had no image.After shutting down and restarting, it returned to normal.The surgery was successfully completed, the operation time was prolonged and the surgical risk factor was increased.Additional information was received.The duration of the delay was unknown.The patient was in the room at the time of the delay.In the physician¿s opinion, the delay did not contribute to a death or serious injury to the patient.No intervention was required due to the delay.After troubleshooting, the problem was successfully resolved.The visualization issue (no image) was assessed as not reportable.The delay in surgery which resulted in an increase risk to the patient was assessed as mdr reportable.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot s1522462 and no internal actions related to the complaint was found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).

• 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: 19923706
• Report Number: 2029046-2024-02621
• Device Sequence Number: 15293884
• Product Code: OBJ
• UDI-Device Identifier: 10846835000139
• UDI-Public: (01)10846835000139(11)240430(17)250428(10)S1522462
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Catalogue Number: SNDSTR10
• Device Lot Number: S1522462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male