MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 05/17/2019

Event Type  Death  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.A manufacturing record evaluation was performed for the finished device 30178191l number, and no internal actions related to the reported complaint condition were identified.(b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.During the procedure, the carto 3 system displayed error 6150.The eco cable was replaced, and the issue did not resolve.The sounstar eco sms 8f catheter was changed and the issue did not resolve.Then, the soundstar catheter (reprocess sdstr eco 8f-90 sms-distributed product) was replaced and the issue resolved.The sounstar eco sms 8f catheter ¿magnetic sensor error¿ issue was assessed as not reportable.The incidence of magnetic sensor error was easy detectable by the user.The catheter was inoperable, since it cannot be visualized on the carto 3 system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.It was also reported that the workstation was not able to receive impedance data, the mapping catheter (reprocess sdstr eco 8f-90 sms-distributed product) was replaced and the ep recorder got the data.The serial data communication cable for the carto system ¿m490021¿ was re-seated, the patient interface unit (piu) was replaced to generator cable and the issue did not resolve.The caller originally thought it was a surpoint issue but was then advised that if the workstation is not getting impedance, the visitag and surpoint would not work.The piu, workstation, and the generator were rebooted, and the impedance was then displayed.The caller also stated that the vizigo sheath would not pair with the catheter.The reboot resolved that issue and the case continued.The carto 3 system issues with the ¿communication issue-smartablate¿ and the ¿ carto application issue/error message¿ were assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The smartablate generator issue with ¿no communication ¿ generator- carto¿ was assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.During the ablation phase, the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by intracardiac ultrasound.There was no evidence of steam pop.The irrigation was at 2cc in continuous flow, 8cc when applied <30 watts and 15cc when applied >30 watts.A transseptal puncture had been performed.Reminder of the procedure was aborted.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.The patient was then transferred to the operating room (or) to have surgery for perforation repair.At an unspecified point, the patient expired.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, the patient had a low ef prior to the procedure.The patient event was assessed as mdr reportable as any serious injury that results in patient¿s death is to be considered serious.

Manufacturer Narrative

Additional information was received on june 12, 2019.It was reported that during the ablation phase, the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by intracardiac echo (ice).Patient had an immediate pericardiocentesis performed and blood drained from space was being returned to the patient to support blood pressure.Although access was established in the pericardium.It was noted that the patient began to form clot in the pericardial space.Patient¿s ejection fraction entering procedure was already low and was not tolerating the blood clot in the pericardial space.Patient survived procedure and operating room and was in recovery though with significant reduction in hemodynamic status, requiring placement of an impella cardiovascular assist device.There were vascular complications and ultimately the patient succumbs to the sustained injuries and expired.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related, the patient had low ejection fraction with no compensation.Manufacturer's reference # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8672305
• MDR Text Key: 147148944
• Report Number: 2029046-2019-03236
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30178191L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; EP RECORDER; REPROCESS SDSTR ECO 8F-90 SMS; SMARTABLATE GENERATOR KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; VIZIGO SHEATH
• Patient Outcome(s): Death; Required Intervention