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

Catalog Number D134804

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

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

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The biosense webster, inc.Product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.While ablating the anterior free wall at about 40w, the physician felt a steam pop.There was an impedance spike, and immediately the ablation was stopped.A cardiac tamponade was confirmed by intracardiac echocardiogram (ice).A pericardiocentesis was performed and 700 cc of fluid was removed from the pericardial space.It was noticed that there was char on the tip of the catheter.The patient was reported to be in stable condition and was transferred to the operating room (or).It is unknown at this time if any surgical intervention was performed or if extended hospitalization was required.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.The issue of a steam pop in itself is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon and not mdr reportable.The char issue was assessed as not mdr reportable.Char is a physical phenomenon of radio frequency and can be the normal result of an ablation process.The presence of char on the electrodes does not represent a serious injury in itself nor is necessarily the result of device malfunction.On november 18, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation, and it was reported that upon initial visual inspection, char is observed on distal tip.

Manufacturer Narrative

Additional information was received on december 13, 2019 and it was reported that the patient was a female, therefore, section a3.Sex was updated and ¿f¿ was selected.It was confirmed that surgical intervention was also required, therefore, section h6.Method codes was populated with ¿no code available¿.H6: patient code of ¿no code available¿ represents ¿surgical intervention¿.Extended hospitalization was required, therefore, section b 2.Is hospitalization initial/prolonged was selected.It was also reported that during the ablation phase, after several areas of the right ventricular outflow tract (rvot) were ablated and while ablating the anterior free wall at about 40w, the physician felt and heard a steam pop.When reviewing impedance drop, after the physician noticed steam pop, a spike in impedance was noted and ablation was immediately stopped.The patient was reported to be in stable condition and was transferred to the operating room, where chest was opened to confirm bleeding had stopped in the rvot.Extended hospitalization was required for recovery from the surgical procedure.The patient has fully recovered.Physician¿s opinion on the cause of the event is that it was procedure related.No transseptal puncture was performed.Flow setting was 15 ml for burning at 40 w.Graph, dashboard, vector and visitag force visualization features were used during the procedure.Visitag parameters were range 2 mm, time 3 seconds, force over time 25% over 3 g and total time color option.There were no error messages observed on biosense webster, inc.Equipment during the procedure.Investigation summary: it was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.While ablating the anterior free wall at about 40 w, the physician felt a steam pop.There was an impedance spike, and immediately the ablation was stopped.A cardiac tamponade was confirmed by intracardiac echocardiogram (ice).A pericardiocentesis was performed and 700 cc of fluid was removed from the pericardial space.It was noticed that there was char on the tip of the catheter.The device was visually inspected, and it was found that there was char in distal tip (dome).The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested, and it was working properly.The force values were observed within specifications.Then, electrical testing was performed on the catheter and it was found within specifications.No electrical malfunctions were observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed, and it was found within specifications.The catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint regarding char has been confirmed.In addition, char is a physical phenomenon of radio frequency (rf); it can be the normal result of the ablation process.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 9376218
• MDR Text Key: 180627932
• Report Number: 2029046-2019-03933
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2020
• Device Catalogue Number: D134804
• Device Lot Number: 30269871M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention