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

Model Number D134805

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

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).Initial reporter phone: (b)(6).The event day was not provided; only the event month as may and event year of 2020 was provided.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered esophageal injury requiring omeprazol.The event was discovered post use of biosense webster products.The patient was examined by a gastroscopy 2 days after pvi procedure.During the examination physicians found thermal lesions in the esophagus.The physician commented that the cause of the event may be changes in the carto 3 system v7 software.The incidence of lesions increased after the installation v7 workstations.Physician assumes that something was changed in the carto 3 system software in v7.The patient did not require extended hospitalization, only close monitoring, and had fully recovered.The patient was given a gastric acid inhibitor, like omeprazole.No lesions were big enough to required a stent.The physician used power control mode with high power short duration ablation strategy (50 watts for 10 sec maximum).They used v7 software, ablation index between 350-450, 50watts power.Short time ablation on posterior wall was used as a strategy to prevent esophageal injury.There were no error messages displayed on the biosense webster equipment during the procedure.The system did not indicate to re-zero the catheter.The esophageal injury was confirmed with gastroscopy.Graph (taken from ct for re-zero), dashboard, vector, visitag were used for force visualization.Visitag parameters were 4mm for 3 sec, ablation index as color option.Stability, time, ablation index were used as additional filter.The event was assessed as not reportable against the carto 3 system.The carto® navigation system is a 3-d electroanatomical cardiac navigation system.It provides 3-d anatomical reconstruction and real-time electrical activity of the heart and ensures precise real-time tracking of catheter tip location.There is no direct patient contact.Thus, these complications are likely related to the catheter, not the mapping system.An evaluation of the carto 3 system is still in progress.If additional information is received, the reportability will be reassessed.The event is being reported serious injury against the ablation catheter (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

On (b)(6) 2020 it was discovered that field b2.Is required intervention was inadvertently left blank in the 3500a initial medwatch report.The field has now been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10255814
• MDR Text Key: 199264052
• Report Number: 2029046-2020-00839
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; UNKNOWN GENERATOR.
• Patient Outcome(s): Other; Required Intervention