MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO NAV; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	D134301
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pre pulmonary vein isolation (pvi) cardiac ablation while mapping with a lasso nav catheter, the patient experienced a cardiac tamponade treated with a pericardiocentesis.Pre pvi ablation, while left atrium (la) mapping with a lasso nav catheter, the cardiac rhythm started to rise.Trans thoracic echo revealed pericardiac tamponade / pericardial effusion treated with a pericardiac puncture/drain, and 600ml of blood was removed from the pericardium.The physician was paying attention to the vital signs because the transseptal puncture (tsp) was not easy, and the posterior roof of the la was close to the tsp needle.The patient is stable for now.The surgery was delayed.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 16-jul-2025.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report 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 reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 21-jul-2025.The event occurred during the transseptal puncture phase.The physician's opinion on the cause of the adverse event is a failed transseptal puncture.The first attempt was a bit posterior and the physician had no blood reflux.Transseptal puncture sites performed during the procedure were one, two attempts.No ablation was performed.Due to the additional information received, reassessed the event under the lasso nav catheter as a non-reportable concomitant product.Therefore, updated h6.Health effect - clinical code, h6.Health effect - impact code and h6.Medical device problem code fields.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO NAV
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: 22538519
• Report Number: 2029046-2025-02376
• Device Sequence Number: 18147045
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(17)271108(10)31497082L
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: D134301
• Device Lot Number: 31497082L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2024
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; THMCL SMRTTCH,BI,NAV,TC,D-F,C3; UNK TRANSSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown