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

Model Number	D134301
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a lasso® nav eco variable catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a signal noise occurred at the lasso® nav eco variable catheter 15-16.Timing when complaints occurred was immediately after cardiac insertion.The cable was changed but the issue continued.The issue was resolved by changing the lasso® nav eco variable catheter to another one.The procedure was continued.Noise and electrical potential loss: noise and potential loss occurred.In intracardiac only, both carto3 and lab, the catheter was in the patient¿s body at the time of the noise.During left atrium (la)-mapping, blood pressure decreased, and drugs were injected, but only pulse increased.Pericardial effusion was confirmed by echocardiography.Thereafter, drainage was performed.800 cc of venous blood was drained.Hemodynamics was improved, and the patient was followed up in the intensive care unit (icu).Cardiac tamponade: atrial septal puncture was performed by rf needle.Ablation was not performed.Steam pop was not confirmed.The physician's opinions on the relationship between the event and the product was that since venous blood had been drained, it was considered that the rv catheter was advanced to the apex of the heart.There were no abnormalities observed prior to and during use of the product.Additional information was received.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related.Since venous blood had been drained, it was considered that the rv catheter was advanced to the apex of the heart.Medication and cardiac drainage were conducted.Outcome of the adverse event was improved.Generator used was a jll generator.No ablation catheter involved.Ablation was not conducted.There was no issue with the vizigo.The noise issue was assessed as non mdr reportable for bad/partial ecg (bs or ic).The risk to the patient was low.Since the adverse event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30919452l and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 28-mar-2023.The duration of hospitalization was prolonged.Reason was due to bradycardia, the patient was scheduled to be discharged from the hospital after pacemaker implantation, but ablation was performed again on (b)(6) 2023 at the request of attending physician, and treatment was completed without any problem.They got a report that a pacemaker would be implanted at a later date.Relevant tests/laboratory data ---none.Other relevant history ---none.Therefore, h6.Health effect - impact code and b2.Is hospitalization initial/prolonged fields were processed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• 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: 16463925
• Report Number: 2029046-2023-00432
• Device Sequence Number: 17754713
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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 Expiration Date: 10/07/2025
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30919452L
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; NON BWI-JLL GENERATOR; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNKNOWN BRAND RF NEEDLE; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 54 KG