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 Code	Cardiac Perforation (2513)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar catheter and the patient experienced cardiac perforation treated with pericardiocentesis and prolonged hospitalization.It was reported that during an afib case with a pericardial effusion was noticed in the patient.The physician was checking intracardiac echocardiography (ice) with the soundstar catheter and a pericardial effusion was noticed.The pericardial effusion was confirmed via echo.The medical intervention provided was a pericardiocentesis; it is unknown how much fluid was removed.The patient was in stable condition.The physician believes that the soundstar catheter may have caused a perforation, as the physician was having difficulty accessing the ventricle, but the information has not yet been confirmed.A new varipulse catheter was opened for the procedure, but it was never inserted into the patient.A webster cs catheter and a soundstar catheter were the only bwi devices inside the patient for the procedure.No ablation had been performed for the procedure.Additional information was later received indicating the physician¿s opinion on the cause of this adverse event was patient condition and the anatomy of the patient.The outcome of the adverse event was reported as fully recovered (no residual effects).The patient required extended hospitalization because of an overnight stay.Relevant tests/laboratory data presented was that transthoracic echocardiogram (tee) was performed.The procedural activated clotting time (act) was over 350.No catheter exchanges occurred during the procedure.One transseptal puncture site was performed during the procedure with a bayless needle.The patient did not require cardiac surgery.The event may have occurred when inserting ultrasound or rv catheter, but it is unknown.
Additional Manufacturer Narrative
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.However, if the product or product id numbers are 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.Note: for field d4: udi: as the serial number for the device involved in the event was not provided, 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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23824162
• Report Number: 2029046-2025-04177
• Device Sequence Number: 21325559
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/16/2025
• 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: 8.5 FR VARIPULSE CATHETER; BAYLESS NEEDLE; UNK_CARTO 3; UNK_TRUPULSE GENERATOR; UNK_WEBSTER CS WITH AUTO ID
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male
• Patient Race: White