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

Model Number NS7TCFL174HS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/10/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 312737410
• Report Number: 2029046-2023-00727
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/11/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female