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

Catalog Number	BD710FJ282RTS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a webster cs catheter and an optrell mapping catheter with trueref technology and prior to ablation energy delivery, the patient experienced a pericardial effusion that required drainage and prolonged hospitalization.During mapping phase, prior to ablation energy delivery, the patient had a pericardial effusion.This was noted after they went transseptal with the versacrest wire.The optrell catheter was in the left atrium for mapping to confirm where they were and noticed some pericardial fluid in the right ventricle.The pericardial fluid was confirmed on ice and x-ray.At this point, the physician aborted the procedure and provided medical intervention by draining the pericardial fluid from around the heart by doing pericardiocentesis.After the pericardial fluid was drained, the patient remained stable which was also the last known status.The case was aborted while mapping in the left atrium.The outcome of the adverse event was that the patient fully recovered (no residual effects).The patient required extended hospitalization, because of overnight instead of being discharged same day.On 27-jun-2025, additional information was received indicated that the versacross wire was used to cross the septum, but it was not determined what caused the effusion.The adverse event was discovered during use of biosense webster products (soundstar, webster cs, & optrell catheters).The physician¿s opinion on the cause of this adverse event was that the physician had difficulty placing the cs catheter in the cs and so a webster cs was exchanged for a boston polaris cs catheter.The physician thought this may have contributed to the effusion.Catheter exchanges occurred during the procedure were four.One transseptal puncture site was performed during the procedure.No evidence of steam pop, since no ablations were performed.The patient did not require cardiac surgery.Based on the new information received wherein the physician reported the cause of the adverse event may be the webster cs catheter, as he had trouble placing the cs catheter inside the coronary sinus, the adverse event is reportable under the webster cs catheter additionally, the optrell was used for mapping prior to the adverse event (and the event was discovered during the mapping phase) therefore adverse event will also be reported against the optrell mapping catheter with trueref technology.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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
It was reported that a patient underwent an atrial fibrillation ablation procedure with a webster cs catheter and an optrell mapping catheter with trueref technology and prior to ablation energy delivery, the patient experienced a pericardial effusion that required drainage and prolonged hospitalization.Information was received indicated that the versacross wire was used to cross the septum, but it was not determined what caused the effusion.The adverse event was discovered during use of biosense webster products (soundstar, webster cs, & optrell catheters).The physician¿s opinion on the cause of this adverse event was that the physician had difficulty placing the cs catheter in the cs and so a webster cs was exchanged for a boston polaris cs catheter.The physician thought this may have contributed to the effusion.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 lot number 31641037m 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.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: 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: 22401297
• Report Number: 2029046-2025-02186
• Device Sequence Number: 8353568
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: (01)10846835002430(17)280502(10)31641037M
• Combination Product (Y/N): N
• 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
• 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 Catalogue Number: BD710FJ282RTS
• Device Lot Number: 31641037M
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2025
• 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: BAYLIS VERSACROSS ACCESS SOLUTION, REF: VXSK0122.; BOSTON POLARIS CS CATHETER.; CARTO 3 SYSTEM.; FARAPULSE¿ PFA SYSTEM (BOSTON SCIENTIFIC).; OPTRELL, 36 ELECTRODES, F-J.; SOUNDSTAR ECO SMS 10F CATHETER.; VERSACREST WIRE.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female