MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
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 31660411m and no internal action 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.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).
Event or Problem Description
During an idiopathic ventricular tachycardia (idvt) ablation procedure with a webster coronary sinus (cs) catheter, the patient experienced pericardial effusion treated with pericardiocentesis and removal of 200ccs of blood.The patient was transferred to intensive care unit (icu) for 24 hours observation.It was reported that after mapping in the right atrium and right ventricular outflow tract (rvot) and going retrograde into the left ventricular outflow tract (lvot), they had noticed the patient had a pericardial effusion.No ablation had occurred.They noticed on the vivid iq ultrasound machine during intracardiac echocardiography (ice) manipulation.Pericardiocentesis was performed and extracted 200cc's of blood.The patient had displayed no symptoms.The patient status is currently stable and will be held overnight in the icu for 24-hour observation and the pericardial effusion is cleared.The thermocool smarttouch sf catheter, webster cs catheter, and reprocessed sterilmed soundstar® catheter were the only biosense webster inc.(bwi) products in the body at the time of the event.The reporter stated the only catheter available for return is the reprocessed sterilmed soundstar® catheter.The case was aborted.The physician¿s opinion on the cause of this adverse event was that he believes a small perforation occurred when he was manipulating the cs catheter closer to the lateral left atrium (very far out in the cs).When they noticed the effusion on ice, the physician immediately wanted to measure it and make sure the patient was stable.The physician performed pericardiocentesis and got around 200cc¿s of blood.The outcome of the adverse event was fully recovered (no residual effects).The patient required extended hospitalization because the patient left the hospital room with the tube still in his chest ready to drain blood if anything happened while on the floor.The patient went to the icu.No catheter exchanges occurred during the procedure.No transseptal puncture sites were performed during the procedure.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of ablation.No error messages observed on biosense webster equipment during the procedure.The force visualization features used were graph, dashboard, and vector.

• Brand Name: WEBSTER CS
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23438555
• Report Number: 2029046-2025-03649
• Device Sequence Number: 4758599
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: (01)10846835002409(17)280527(10)31660411M
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: BD710DF282CT
• Device Lot Number: 31660411M
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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: CARTO 3 SYSTEM.; NGEN RF GENERATOR, US.; REPROCESSED (STERILMED) SOUNDSTAR® CATHETER.; THMCL SMTCH SF BID, TC, D-F.; VIVID IQ ULTRASOUND MACHINE.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White