MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	BN7TCFJ4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 30840214m 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 4.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).
Event or Problem Description
It was reported that a 93-year-old female patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter.The patient suffered complete heart block requiring a temporary pacemaker and scheduled a permanent pacemaker.Upon the ablation ending, the patient went into complete heart block.Temporary pacing was being conducted and the patient was scheduled for a permanent pacemaker.Additional information was received.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.The patient received a pacemaker.The patient outcome was unknown but assumed to have improved after getting a pacemaker.The physician believed the result was due to weak conduction after being in tachycardia for so long.

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15333063
• Report Number: 2029046-2022-02064
• Device Sequence Number: 20454528
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: 06/06/2025
• Device Model Number: BN7TCFJ4L
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30840214M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: 6FR DEFL,4P,D,SD,5MM,12PR; 6FR DEFL,4P,D,SD,5MM,12PR; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female