MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35DDH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a ventricular tachycardia ablation procedure with a thermocool® sf nav bi-directional catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that 2 issues occurred; could not conduct the ablation due to an ¿impedance too high¿ error.Blood pressure dropped during the second ablation at rvot.Echocardiography confirmed pericardial effusion, and drainage was performed.Hemostatic agent was used to stop bleeding and the procedure was completed.The procedure ended with insufficient treatment.Timing was when; when catheter was inserted into the intracardiac after mapping and dc.The ablation catheter was extracardiac during dc.Body surface dc was used.2 hours after the start of treatment.During ablation.Procedure was completed by ; restarted the system and continued the procedure.Drainage.Cardiac tamponade ablation was performed before pericardial effusion or tamponade was identified.Steam pop was not observed.Irrigation catheter¿s flow rate setting was low 8ml, high 15ml.The ablation was conducted at 30 w for 60 seconds, and the visitag was displayed as total time because the catheter had no cf.Progress (current patient's condition) --- hemostatic agent was administered and open chest surgery was not performed.The patient was returned to icu and condition tended to improve.Physician assessment of the health problem --- serious.Coloring setting of visitag --- total time.The physician's opinions on the relationship between the event and the product was that it may have pushed too hard when raising the catheter to rvot.The issue was procedure related.It was not during ablation.There were no abnormalities observed prior to use of the product there were no abnormalities observed during use of the product.History of medical history/treatment/other diseases currently being treated, etc --- myocardial infarction.Laboratory tests and results --- none in particular.Additional information: generator used ngen---system number: 23090170fg, product code: d138404.Transseptal puncture needle--- rf needle (baylis medical).No error indication during ablation, but after performing body surface dc (270j) during the procedure, impedance was not displayed and the system restart was required.Upon the system restart, the ablation catheter that had been inserted into the rvot was removed from the patient's body and reinserted.Progress (current patient's condition) patient was admitted to icu and hospital stay was extended for insertion of pericardial drain.On (b)(6), the patient's outcome was confirmed to be improved.Since the event is 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 is to be considered serious.
Additional Manufacturer Narrative
On 20-jun-2023, bwi received additional information regarding the event.Outcome of the adverse event was improved.The patient required extended hospitalization because of icu stay and pericardial drain insertion.Relevant tests/laboratory data myocardial infarction.Transseptal puncture was performed with rf needle(baylis medical).No error messages observed.Generator information was a ngen generator, system number: (b)(6), model: d138404.Servicing was not needed.Bq is not involved in purchase order activities.Device not available for return.The physician information was also updated in section e (dr.(b)(6)).On 30-jun-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30645206l number, and no internal action 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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17071989
• Report Number: 2029046-2023-01235
• Device Sequence Number: 6105172
• Product Code: LPB
• UDI-Device Identifier: 10846835003192
• UDI-Public: 10846835003192
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S025
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 10/07/2024
• Device Model Number: BNI35DDH
• Device Catalogue Number: BNI35DDH
• Device Lot Number: 30645206L
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2021
• 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 RF NEEDLE; CARTO 3 SYSTEM; CARTO VISITAG MODULE; NGEN RF GENERATOR JAPAN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male