MAUDE Adverse Event Report: Biosense Webster Inc SOUNDSTAR; Catheter, Ultrasound, Intravascular

Catalog Number	10439236
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia ablation procedure with a qdot micro catheter and a soundstar catheter and the patient experienced cardiac perforation and syncope which required pericardiocentesis.After the atrial tachycardia ablation with the qdot catheter, a pericardial effusion was noticed.The patient had been stable during the entire procedure.Thirty-five minutes after the patient left the room post ablation, the patient had a drop in blood pressure and they became unconscious.It was unknown how the pericardial effusion was confirmed.The medical intervention provided was a pericardiocentesis and 180cc of fluid was removed.An additional 900 ml fluid was removed during the night after the procedure.Patient stayed in the hospital for two nights because the effusion grew.The patient was reported to be in stable condition.They found a trace pericardial effusion in the left ventricle before the procedure and when they checked on intracardiac echocardiogram after the procedure, the pericardial effusion was the same.The physician could not confirm what caused the pericardial effusion after the procedure but believed the soundstar catheter may have perforated the right ventricle.Force visualization features used were vector, graph, visitag and the parameters for stability were 3,3, 25 % , 3g.Additional filter used with the visitag was respiratory gaiting.Color option used prospectively was impedance drop 2-10 ohms.
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.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50545889
• Report Number: 3013300026-2026-02866
• Device Sequence Number: 10311874
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: 10846835008869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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 Catalogue Number: 10439236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Race: White