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 Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on 4/22/2019.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.A manufacturing record evaluation was performed for the finished device 30064113l number, and no internal action was found during the review.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis) and pleural effusion.During the procedure, the ventricular tachycardia was mapped with a pentaray catheter and resulted in focal and not ischemic.Before any ablation was performed, the patch got disconnected from a sensor cable near the neck.This resulted in ever so slightly repositioning the patient to get access to the cable which was reconnected to the patch and the procedure continued.At this time, cardiac tamponade was confirmed by intracardiac echo (ice).A very fast ablation was performed on the focal slight while the chest was being prepped to drain the effusion.After two lesions, the catheters were pulled back into the right atrium (ra) and a transseptal puncture was performed to get access to the left ventricle (lv).Pericardiocentesis was performed to remove 10 cc o fluid from the pericardium.The effusion was still present, and the physician was going to drain again; however, it was noticed the effusion disappeared from ice.A chest x-ray was taken which revealed fluid around the patient¿s left lung.It is unknown if further intervention was performed.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis) and pleural effusion.During the procedure, the ventricular tachycardia was mapped with a pentaray catheter and resulted in focal and not ischemic.Before any ablation was performed, the patch got disconnected from a sensor cable near the neck.This resulted in ever so slightly repositioning the patient to get access to the cable which was reconnected to the patch and the procedure continued.At this time, cardiac tamponade was confirmed by intracardiac echo (ice).A very fast ablation was performed on the focal slight while the chest was being prepped to drain the effusion.After two lesions, the catheters were pulled back into the right atrium (ra) and a transseptal puncture was performed to get access to the left ventricle (lv).Pericardiocentesis was performed to remove 10 cc o fluid from the pericardium.The effusion was still present, and the physician was going to drain again; however, it was noticed the effusion disappeared from ice.A chest x-ray was taken which revealed fluid around the patient¿s left lung.It is unknown if further intervention was performed.There¿s no information regarding extended hospitalization or the patient¿s outcome.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.Manufacturer's reference number: (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: 8593430
• MDR Text Key: 144541739
• Report Number: 2029046-2019-03090
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30064113L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention