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

Catalog Number	10439011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Ischemic Heart Disease (2493)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a soundstar and the patient experienced st elevation/myocardial infarction that caused case cancellation and required patient to need prolonged hospitalization.Before brokenbrough, st elevation occurred.The st normalized within minutes but the ablation procedure was cancelled just in case.Patient recovered, however.Required extended hospitalization for follow up observation.The physician reported the cause of the adverse event is unknown.The patient originally had a history of various treatments and had been treated for coronary procedures.Patient has a history of myocardial infarction and angina pectoris.Ablation was not performed.No abnormality observed prior to use of the product.On 2-sep-2024, additional information was received indicting that no mapping was performed and the only catheter inside the patient's body was the soundstar catheter.As such, the awareness date is the date additional information was received indicating the soundstar was the only device inside the patient's body and that there was a new area of infarct.The patient had a history of myocardial infarction, and the physician believed that a new infarct area developed during this case.
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 ref.#: (b)(4).
Additional Manufacturer Narrative
On 19-sep-2024, additional information was received indicating there was no malfunction with the soundstar.The physician does not believe that the soundstar contributed to the adverse event.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot e8548761 and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (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: 20136263
• Report Number: 2029046-2024-02947
• Device Sequence Number: 3226710
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: (01)10846835008852(17)250407(10)E8548761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup

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: 04/07/2025
• Device Catalogue Number: 10439011
• Device Lot Number: E8548761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Male