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

Catalog Number	D134301
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a lasso nav wherein a thrombus/clot was found on the catheter tip and the procedure was cancelled.The patient required medicinal intervention and hospitalization.A clot was discovered attached to the lasso nav catheter in the left atrium, which was noticed on intracardiac echocardiography (ice).The clot formation was discovered after the initial mapping of the left atrium.The patient was given heparin (a large amount of heparin to dilute the clot) and the procedure was cancelled.There was no patient injury, however, the patient required extended hospitalization as the patient needed neurology monitoring.The physician had some difficulty when they tried to go transseptal and it took longer than usual.The physician believes that either the patient already had a clot that they didn't notice or the clot was caused by the 45 mins it took to go transseptal.It was reported that the physician does not use heparin until post transseptal, he also does not clear the left atrial appendage (laa) with "sound" (ultrasound).There was no error message from the equipment, no product problem, or any issues related to temperature and flow on the catheter.The physician believed that the thrombus observed caused a potential risk to the patient because if it is dislodged, it could cause a stroke, however, he thinks he took the necessary steps to minimize that probability.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a lasso nav wherein a thrombus/clot was found on the catheter tip and the procedure was cancelled.The patient required medicinal intervention and hospitalization.A clot was discovered attached to the lasso nav catheter in the left atrium, which was noticed on intracardiac echocardiography (ice).The clot formation was discovered after the initial mapping of the left atrium.The patient was given heparin (a large amount of heparin to dilute the clot) and the procedure was cancelled.There was no patient injury, however, the patient required extended hospitalization as the patient needed neurology monitoring.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.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: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21415057
• Report Number: 2029046-2025-00473
• Device Sequence Number: 21143516
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D134301
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/01/2025
• 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: NGEN GENERATOR.; NGEN PUMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White