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

Catalog Number D132705

Device Problem Pacing Problem (1439)

Patient Problem Atrial Tachycardia (1731)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a male patient underwent a left sided ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and developed atrial fibrillation.After placing a quad catheter (non-biosense webster, inc.) in the right ventricle (rv) and ablation catheter (thermocool® smart touch¿ bi-directional navigation catheter) in the right atrium (ra), a josephson stimulation protocol from the right ventricle catheter was started and induced a rapid and unstable ventricular tachycardia which had to be cardioverted.Upon cardioversion, ecg signal was lost and ecg with 100ms cycle length noise was observed on body surface (bs) and intracardiac (ic) signals being displayed on carto and ep recording system, which apparently induced atrial fibrillation (afib).The pacing leads were connected to the primary pacing port.Defibrillator and anesthesia monitors were available to monitor the patient¿s heart rhythm.To stop the noise, the ablation catheter and cable were disconnected.The patient interface unit (piu) was also turned off.Replacing the cable and connecting the ablation catheter restarted the issue.Patient interface unit (piu) was then turned off and a new ablation catheter was used, and the issue was resolved.The case was delayed for 30 minutes.No medical/surgical intervention or extended hospitalization was required.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the event is that it was biosense webster, inc.Product malfunction related.It was also reported that error 8 appeared on the screen.There was no ablation at the time error 8 occurred.The patient was cardioverted and the system started stimulating the ablation catheter (the only catheter connected to the patient interface unit) by itself and then this error occurred.Atrial tachycardia it is to be considered serious and mdr-reportable if it was directly attributed to product malfunction or if medical/surgical intervention or extended hospitalization was required for treatment or prevention of permanent damage to the patient.In this case, interventions were not required; however, the description suggests that there was noise on the catheter that resulted in pacing of the heart and inducibility of atrial fibrillation in the patient.The issue of pacing unwanted was assessed as a reportable issue.The issue of bad/ partial ecg (bs or ic) was assessed as a not reportable issue.

Manufacturer Narrative

Additional information was received on (b)(6)2019 , and the following information was provided.Unwanted pacing was being delivered, stimulation was being delivered from the patient interface unit (piu) into the right atrium where the ablation catheter was (only catheter connected to the patient interface unit).The pacing was routed through the carto system but at the time of the issue, none channel was selected, and the ep recording system had selected a catheter that wasn¿t connected to the carto.The patient was cardioverted and the cardioversions caused damage to the catheter manifesting as black residue on the connection between the ablation catheter and the cable.According to the physician, the catheter did not withstand the external cardioversion.The force visualization features used during the case included graph, dashboard and vector.The connector issue was assessed as a not reportable issue.Since the device or the cable have the connector issue , the device can¿t be used.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Manufacturer's reference # pc-000495845.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on (b)(6) 2019, and it was noted that upon initial inspection, no visual damage or anomalies were observed.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.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Investigation summary it was reported that a male patient underwent a left sided ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and developed atrial fibrillation.After placing a quad catheter (non-biosense webster, inc.) in the right ventricle (rv) and ablation catheter (thermocool® smart touch¿ bi-directional navigation catheter) in the right atrium (ra), a josephson stimulation protocol from the right ventricle catheter was started and induced a rapid and unstable ventricular tachycardia which had to be cardioverted.Upon cardioversion, ecg signal was lost and ecg with 100ms cycle length noise was observed on body surface (bs) and intracardiac (ic) signals being displayed on carto and ep recording system, which apparently induced atrial fibrillation (afib).The pacing leads were connected to the primary pacing port.Defibrillator and anesthesia monitors were available to monitor the patient¿s heart rhythm.To stop the noise, the ablation catheter and cable were disconnected.The patient interface unit (piu) was also turned off.Replacing the cable and connecting the ablation catheter restarted the issue.Patient interface unit (piu) was then turned off and a new ablation catheter was used, and the issue was resolved.The case was delayed for 30 minutes.In addition, unwanted pacing was being delivered, stimulation was being delivered from the patient interface unit (piu) into the right atrium where the ablation catheter was (only catheter connected to the patient interface unit).The pacing was routed through the carto system but at the time of the issue, none channel was selected, and the ep recording system had selected a catheter that wasn¿t connected to the carto.The patient was cardioverted and the cardioversions caused damage to the catheter manifesting as black residue on the connection between the ablation catheter and the cable.An analysis on pictures that were provided by the customer was performed.Based on the images, it appeared that noise was observed on the screens.However, the customer complaint could not be confirmed based on the pictures that were provided.The complaint device was returned and was visually inspected, and it was found in good condition.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 test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection tests 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 catheter passed all specifications.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).

Manufacturer Narrative

Further investigation was processed after the previous investigation completion, therefore, an updated investigation summary is below.Investigation summary it was reported that a male patient underwent a left sided ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and developed atrial fibrillation.After placing a quad catheter (non-biosense webster, inc.) in the right ventricle (rv) and ablation catheter (thermocool® smart touch¿ bi-directional navigation catheter) in the right atrium (ra), a josephson stimulation protocol from the right ventricle catheter was started and induced a rapid and unstable ventricular tachycardia which had to be cardioverted.Upon cardioversion, ecg signal was lost and ecg with 100ms cycle length noise was observed on body surface (bs) and intracardiac (ic) signals being displayed on carto and ep recording system, which apparently induced atrial fibrillation (afib).The pacing leads were connected to the primary pacing port.Defibrillator and anesthesia monitors were available to monitor the patient¿s heart rhythm.To stop the noise, the ablation catheter and cable were disconnected.The patient interface unit (piu) was also turned off.Replacing the cable and connecting the ablation catheter restarted the issue.Patient interface unit (piu) was then turned off and a new ablation catheter was used, and the issue was resolved.The case was delayed for 30 minutes.In addition, unwanted pacing was being delivered, stimulation was being delivered from the patient interface unit (piu) into the right atrium where the ablation catheter was (only catheter connected to the patient interface unit).The pacing was routed through the carto system but at the time of the issue, none channel was selected, and the ep recording system had selected a catheter that wasn¿t connected to the carto.The patient was cardioverted and the cardioversions caused damage to the catheter manifesting as black residue on the connection between the ablation catheter and the cable.The device was visually inspected, and it was found in good conditions.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 test was performed on the catheter and it was found within specifications.No electrical malfunction was 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 catheter passed all specifications.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.With the provided pictures the noise reported was confirmed however, this issue cannot be related to the device since no electrical malfunction was observed during the test.Manufacturer's reference # pc-000495845.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 8834064
• MDR Text Key: 152499731
• Report Number: 2029046-2019-03456
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Catalogue Number: D132705
• Device Lot Number: 30171486M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CBL, 34 HYP/34 LEMO, 10'; EP SHUTTLE SYS 100W; PACING STIMULATOR UHS 20; QUAD CATHETER
• Patient Age: 62 YR