MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1313-05-S
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Thrombosis (2100)
Date of Event	05/11/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.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.Concomitant products: carto 3 system (model# m-4800-01 serial# (b)(4)).Smartablate generator.Smartablate pump.Ez steer coronary sinus catheter (model# d-1263-05-s lot# 17639993m).Lasso nav variable eco catheter (model# d-1343-01-s lot#17649146l).(b)(4).
Event or Problem Description
It was reported that an (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a thermocool® sf nav bi-directional catheter and suffered a cardiac arrest (requiring cardiopulmonary resuscitation and pharmacologic support), thrombosis (requiring tissue plasminogen activator), and death.During the procedure, the patient became hypotensive and hypoxic.Post-ablation, the patient was cardioverted.Patient arrested and cardiopulmonary resuscitation (cpr) was performed.Patient was prepared for a cardiac catheterization.Since there may have been a possible embolic event, tissue plasminogen activator (tpa) was administered.It was noted that myocardial stunning may have occurred.Intracardiac ultrasound and transthoracic echocardiogram revealed no pericardial effusion.Initially, the patient was reported to be in unstable condition.Patient required extended hospitalization in the intensive care unit as a result of the adverse event for stabilization and monitoring.Physician¿s opinion regarding the cause of the event is that it was possibly related to post-ablation cardioversion.Injuries have not been confirmed.Additional information was later received that the patient expired.Physician¿s opinion regarding the cause of death is that it was related to an embolus.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).It was reported that an (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a thermocool® sf nav bi-directional catheter and suffered a cardiac arrest (requiring cardiopulmonary resuscitation and pharmacologic support), thrombosis (requiring tissue plasminogen activator), and death.The returned device was visually inspected, and was found in good condition.The catheter was evaluated for carto 3 system performance, and was recognized by the system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The catheter was tested for electrical performance and stockert compatibility, and was found within specifications.Deflection and irrigation tests were performed, which the catheter passed.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root causes of the cardiac arrest, thrombosis and death remain unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6617912
• Report Number: 9673241-2017-00440
• Device Sequence Number: 739415
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)170202(17)200131(10)17636723L
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: 01/31/2020
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17636723L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 81 YR