MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	NS7TCFL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an avrt (atrioventricular nodal reentrant tachycardia) ablation procedure with a navistar¿ electrophysiology catheter and the patient suffered a soft tissue injury requiring surgical intervention for pacemaker.It was reported that the catheter was correctly working but when ablating it moved a bit and part of the his bundle was burnt.The patient needed a pacemaker.Additionally, the reporter confirms the adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patients outcome was reported as unchanged.Extended hospital stay was required.Force visualization features used were graph and vector.
Additional Manufacturer Narrative
It was reported that a patient underwent an avrt (atrioventricular nodal reentrant tachycardia) ablation procedure with a navistar¿ electrophysiology catheter and the patient suffered a soft tissue injury requiring surgical intervention for pacemaker.It was reported that the catheter was correctly working but when ablating it moved a bit and part of the his bundle was burnt.The patient needed a pacemaker.Additionally, the reporter confirms the adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patients outcome was reported as unchanged.Extended hospital stay was required.Force visualization features used were graph and vector.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30871526m identified no internal actions related to the reported complaint condition.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.Based on the completed, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, 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: 16685982
• Report Number: 2029046-2023-00727
• Device Sequence Number: 12782409
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P990025
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 08/11/2025
• Device Model Number: NS7TCFL174HS
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30871526M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: CARTO 3 SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female