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

Catalog Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure with a non-bwi catheter and soundstar catheter, the patient experienced blood pressure dropped, and pericardial effusion treated with pericardiocentesis with a moderate amount of blood withdrawn.The patient was stable on transfer to icu for further monitoring.The physician commented that either the pfa (pulse field ablation) applications in the svc (superior vena cava) or the manipulation of the soundstar catheter most likely caused the pericardial effusion.The report indicated that the patient had an adverse event/pericardial effusion.Post completion of pfa with the boston scientific farawave catheter the physician advanced the catheter into the svc, and shortly after applying pfa to the svc the anesthesiologist reported that the patient's blood pressure had dropped.A pericardial effusion was discovered using intracardiac echo.Pericardiocentesis was completed and a moderate amount of blood was withdrawn.The physician commented that either the pfa applications in the svc or the manipulation of the soundstar catheter most likely caused the pericardial effusion.The products used during the procedure were a 10fr ge soundstar catheter, octaray d curve catheter, boston scientific polaris cs catheter, boston scientific faradrive sheath, boston scientific farapulse catheter, transeptal wire unknown, carto system, boston scientific farapulse system, and ngen generator.The information received indicated that the physician¿s opinion was retroflexing upward with the ice (intracardiac echocardiography) catheter in the right atrium may have contributed to the event.The outcome of the adverse event was that the patient fully recovered (no residual effects), and the patient was stable post op with improvement.Other relevant history/preexisting condition was low ef (ejection fraction), hypertension, and diabetic.No generator was in use in this case.The procedural act (activated clotting time) was 350.One transseptal puncture was performed during the procedure.The ablations performed during this procedure were 112 applications, boston pfa 23 with 20 in each vein and 32 ablations in the posterior wall.
Additional Manufacturer Narrative
D4: udi: the expiration date and manufacture date are currently not available.Therefore, 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).
Additional Manufacturer Narrative
On 28-feb-2026, the product investigation was completed as the complaint device was discarded.Device investigation details: 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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24408059
• Report Number: 2029046-2026-00590
• Device Sequence Number: 10113527
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 10439072
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10FR GE SOUNDSTAR.; BOSTON SCIENTIFIC FARADRIVE SHEATH.; BOSTON SCIENTIFIC FARAPULSE CATHETER.; BOSTON SCIENTIFIC POLARIS CS CATHETER.; CARTO 3 SYSTEM.; NGEN GENERATOR.; OCTARAY D CURVE.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White