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

Catalog Number	D134301
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso nav and char was found on the tip electrode.After the insertion of the catheter in the left atrium (la), the impedance of the corresponding smart touch sf catheter rapidly increased during right pulmonary vein isolation (rpvi).When the catheter was removed from the patient¿s body and checked, charring was observed on the tip electrode of the catheter.The smart touch sf catheter was replaced and the issue was resolved.Furthermore, towards the end of the procedure, when the corresponding lasso 2515 nav eco catheter was removed from the patient¿s body, charring was observed, similar to that seen on the smart touch sf catheter.Additional information received indicated there were no error messages presented by the system; impedance rapidly increased during rpvi.The generator was set up on power control mode and ablation never continued beyond the impedance cut-off value.There was user miss of changing the catheter setting on the generator side, and the ablation was conducted with the 4mm tip catheter setting during 10 times of ablation at the beginning.Irrigation flow rate was 2ml/min when 35w ablation was performed.The patient was anticoagulated.But act was unknown.Heparinized normal saline was used.The patient has not exhibited any neurological symptoms since the procedure was completed.It was reported the diagnostic catheter (lasso nav) was in close proximity to/in contact with the ablation catheter during ablation.
Additional Manufacturer Narrative
On 28-mar-2025, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 1-apr-2025, additional information was received clarifying the generator used this case was a smartablate generator.As such, this item has been added to section d10.Concomitant medical products.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso nav and char was found on the tip electrode.After the insertion of the catheter in the left atrium (la), the impedance of the corresponding smart touch sf catheter rapidly increased during right pulmonary vein isolation (rpvi).When the catheter was removed from the patient¿s body and checked, charring was observed on the tip electrode of the catheter.The smart touch sf catheter was replaced and the issue was resolved.Furthermore, towards the end of the procedure, when the corresponding lasso 2515 nav eco catheter was removed from the patient¿s body, charring was observed, similar to that seen on the smart touch sf catheter.There were no error messages presented by the system; impedance rapidly increased during rpvi.The generator was set up on power control mode and ablation never continued beyond the impedance cut-off value.There was user miss of changing the catheter setting on the generator side, and the ablation was conducted with the 4mm tip catheter setting during 10 times of ablation at the beginning.Irrigation flow rate was 2ml/min when 35w ablation was performed.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, and microscopic examination of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.No char residues was identified; however, customer mentioned that the charring was wiped off by the physician before the devices return.Furthermore, the user missed changing the catheter setting on the generator side.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The char and the user error issues reported by the customer were confirmed.The potential cause of the issue is traced to user.The instruction for use (ifu) contains the following precautions: do not attempt to operate the lasso variable catheter prior to completely reading and understanding these instructions for use.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released 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: 21713265
• Report Number: 2029046-2025-00938
• Device Sequence Number: 10010287
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(17)270906(10)31434557L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D134301
• Device Lot Number: 31434557L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 04/01/2025; 04/15/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/09/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2024
• 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: BAYLIS VERSACROSS STEERABLE ACCESS SOLUTION; CARTO 3 SYSTEM; OCTA,LNG,48P,3-3-3-3-3,F-CURVE; SMARTABLATE GENERATOR KIT (CN); THMCL SMTCH SF BID, TC, D-F; UNKNOWN BWI DECA NAV; UNKNOWN NGEN SYSTEM
• Patient Sex: Unknown