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

Model Number	D134301
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure that included the use of lasso® nav eco variable catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the blood pressure decreased rapidly while mapping at left atrium (la) with the lasso® nav eco variable catheter.Echocardiography was performed and pericardial effusion was confirmed.Drainage was performed (approximately 500ml of blood), hemostasis was achieved.The patient was transferred to the intensive care unit (icu).The procedure was discontinued.Transseptal puncture was performed.Ablation was not performed.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting: default setting.There were no abnormalities observed prior to and during use of the product.The event occurred during the mapping phase.Additional information was received indicating the adverse event was discovered during use of biosense webster products.The outcome of the adverse event was patient fully recovered (no residual effects).The patient was discharged from the hospital.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features were dashboard.Visitag module was used and parameters for stability were (range; time; fot; tag size) ablation index was used.Color options were tag index.
Additional Manufacturer Narrative
Device investigation details: available 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 30932662l number, and no internal actions related to the complaint was found during the review.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.E1.Initial reporter phone: (b)(6).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 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: 16739390
• Report Number: 2029046-2023-00809
• Device Sequence Number: 12430753
• 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
• Report Date (Section B): 04/13/2023

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 Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30932662L
• 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: 03/16/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CARTO 3 SYSTEM; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-D
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female