MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number NI75TCDH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and patient experienced cardiac perforation treated with surgical intervention.During the ablation of a ventricular tachycardia in the free wall of the right ventricle, they heard a steam pop from the ablation catheter which interrupted the tachycardia.Almost immediately, the personnel realized that the systemic pressure dropped and that the steam pop caused a tamponade.The physician started to prepare the patient in order to extract the excessive blood from the pericardial sac.The operation did not succeed in stabilizing the patient, so the surgical team was called and they had to perform an open heart surgery to close the wound.The situation appeared under control as they were stitching up the patient, but it is unclear whether the patient will suffer long term consequences.It was the physician¿s opinion that the steam pop was not caused by a malfunction of a biosense webster, inc.(bwi) catheter, but he categorized it as a procedural situation.Additional information was received.No transseptal puncture, the tamponade took place in the right ventricle.The steam pop was noted during the use of bwi product, the tamponade was noted after the use of bwi products.No error messages observed on the biosense webster equipment during the procedure.The outcome of the adverse event was improved in a short time.However, unknown in the long time.The ngen generator and navi-star¿ thermo-cool¿ electrophysiology catheter were being used during the procedure.The pentaray nav eco 7fr, d, 2-6-2 was not inside the patient during the adverse event.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 03-apr-2024.The 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 reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on 11-apr-2024, noted a correction to the 3500a follow-up #1 as in error, missed coding under h6.Type of investigation, h6.Investigation findings, and h6.Investigation conclusions.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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: 18862260
• MDR Text Key: 337184246
• Report Number: 2029046-2024-00773
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 31141432M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2023
• 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
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; UNK PUMP; UNK_CARTO 3; UNK_NGEN RF GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male