MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure for ventricular tachycardia (vt) which included the use of an ez steer¿ thermocool® nav bi-directional catheter and experienced heart block requiring implantable cardioverter-defibrillator (icd) for an intervention and hospitalization.The event occurred when the septum of left ventricle (lv) was ablated by thermocool during vt in the middle of the procedure, and when the vt was terminated.The procedure was continued as it was and completed without any problem.The patient still had the left bundle branch block when leaving the room.This event was initially assessed as non mdr reportable.However, on 09-nov-2023, additional information was received which stated that an implantable cardioverter-defibrillator (icd) was implanted in the patient.The patient recovered with no disabilities that interferes with daily activity after an extended hospitalization.With the additional information received, this event is now considered mdr reportable.The awareness date was 09-nov-2023.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 18280662
• Report Number: 2029046-2023-02857
• Device Sequence Number: 5909740
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• 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
• Report Date (Section B): 12/06/2023

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 Catalogue Number: BNI75TCDFH
• 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: 11/09/2023
• Initial Report FDA Received Date: 12/07/2023
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; NGEN RF GENERATOR; OPTRELL, 48 ELECTRODES, D-F; QDOT MICRO, BI, TC, D-F; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 65 KG