MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number NR7TCSIY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/03/2023

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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-02734 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-02735 for product code nr7tcsiy (navistar® rmt thermocool® electrophysiology catheter).

Event Description

It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring per pericardiocentesis, a sternotomy and prolonged hospitalization.After ablation, they were preparing to go left sided and patient became hypotensive.Using ultrasound they saw a pericardial effusion.A pericardiocentesis was performed, an unknown amount of fluid was removed.Then a sternotomy was performed patient was stable when they left the lab to go to the intensive care unit (icu) and hospitalized for a week.Discharged with full recovery.Physician's opinion the cause was ablating on the free wall of the right ventricle where tissue is thinner.No steam pop.Correct settings on devices and no error messages on the equipment.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 19-dec-2023, it was noticed the incorrect manufacture ref # was reported in the supplemental (follow-up) mdr # 1 as "(b)(4)".The correct manufacture ref # is (b)(4).

Manufacturer Narrative

It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring per pericardiocentesis, a sternotomy and prolonged hospitalization.After ablation, they were preparing to go left sided and patient became hypotensive.Using ultrasound they saw a pericardial effusion.A pericardiocentesis was performed, an unknown amount of fluid was removed.Then a sternotomy was performed patient was stable when they left the lab to go to the intensive care unit (icu) and hospitalized for a week.Discharged with full recovery.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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).

• Brand Name: NAVISTAR® RMT THERMOCOOL® 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: 18187589
• MDR Text Key: 328741170
• Report Number: 2029046-2023-02735
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NR7TCSIY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM.; PENTARAY NAV ECO 7FR, F, 2-6-2.; SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF BID, TC, D-F.; UNKNOWN PUMP.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 98 KG