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

Catalog Number NS7TCBL174HS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 12/27/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a right-side atrial tachycardia ablation procedure with a navistar¿ electrophysiology catheter and the patient experienced cardiac arrest that required chest compression, medication and prolonged hospitalization.The patient also experienced a small pericardial effusion that did not require further intervention.Also, thrombosis was discovered in pericardium that required surgical intervention to remove.While performing a right-sided atrial tachycardia case, the patient's heart stopped beating and they went into cardiac arrest.Medical intervention provided were chest compressions and administering of epinephrine to the patient.A small pericardial effusion was confirmed on echocardiogram but due to the size of the effusion, they did not perform any further medical intervention.Patient was stable.Additional information was later received indicated the physician believes that the cause of the adverse event was due to the ablation catheter.Compressions were provided immediately.After the patient was stable and after monitoring the clot, it was decided that care should be provided to remove the clot from the pericardium (tap) in a separate procedure.The patient had to get a procedure to remove the clot from their pericardium, which required extended stay.This patient was very small, so they wanted to closely monitor the patient during their recovery.Patient is fully recovered but required prolonged hospitalization.No transseptal was performed.Ablation was performed.No evidence of steam pop.The event occurred during ablation phase.The ablation catheter was a non-irrigated, non-contact force catheter.

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).

Manufacturer Narrative

On 31-jan-2024, additional information was received indicating the patient was 10 days old.There was a clot in the pericardium.There were no product concerns or malfunctions during the case.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation was completed on 9-feb-2024.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

25-jan-2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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: 18556399
• MDR Text Key: 333402220
• Report Number: 2029046-2024-00260
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008531
• UDI-Public: 10846835008531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NS7TCBL174HS
• Device Lot Number: 31073818M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 01/25/2024; 01/31/2024
• Supplement Dates FDA Received: 01/26/2024; 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 10 DA
• Patient Sex: Male
• Patient Weight: 2 KG