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

Model Number D-1197-17-S

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Cardiac Tamponade (2226); Discomfort (2330)

Event Date 08/04/2016

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: carto 3 system (model# m-4800-01 serial# (b)(4)), stockert generator (model# unknown serial# unknown), coolflow pump (model# unknown serial# unknown).Full udi # information unavailable since the lot number is unknown.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a navistar® thermocool® electrophysiology catheter and suffered a cardiac tamponade (requiring pericardiocentesis), cardiac arrest (requiring defibrillation), and death.The physician gained access via retrograde approach then mapped the left ventricle via point-by-point method.After the bipolar map was constructed, the physician marked the locations he was interested in and proceeded with ablation.After approximately 3 applications (32 seconds total), a steam pop occurred and the physician stopped ablation.A few minutes later, the patient reported dizziness and chest discomfort.The patient was hypotensive and a tamponade was confirmed via fluoroscopy.Pericardiocentesis was performed over the course of 2 hours.The patient was sent for a surgical intervention.During transport, the patient arrested.Resuscitation efforts (defibrillation) were not successful.No autopsy was performed.Factors that may have contributed to the adverse event include history of non-ischemic cardiomyopathy and an enlarged left ventricle (8.5 cm).The physician¿s opinion regarding the cause of the adverse event is that it was related to excessive tip-to-tissue contact.No transseptal puncture was performed, as approach was retrograde.Sheath used was a terumo brown 8 french.Stockert generator was in power control mode, with the power initially set at 45 watts.Power was titrated and reached the target setting a few seconds after the application started.Power was at 50 watts at the time of injury.Irrigated catheter flow was set at 30ml/min.There were no error messages observed on any bwi equipment during the procedure.Patient received anticoagulant during the procedure with activated clotting times maintained at 250-300 seconds.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5917825
• MDR Text Key: 53607880
• Report Number: 9673241-2016-00545
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

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: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: UNKNOWN_D-1197-17-S_JUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/31/2016
• 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
• Patient Outcome(s): Death