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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) procedure with a (b)(6) bi-directional navigation catheter.The patient suffered cardiac tamponade (hypotension with a pericardial effusion).The patient had a small pericardial effusion at the end of the procedure noticed with intracardiac echo.The patient's blood pressure dropped then the soundstar catheter was maneuvered to visualize the small effusion.A transthoracic echo was then performed to confirm the diagnosis.The patient was only monitored, no interventional measures were taken.The patient was stable.The physician did not indicate if they believed biosense webster, inc.Products were responsible for the adverse event.It was reported that there was a "no transducer" message indicated on the siemens ultrasound system, and no recognition on the carto 3 system when the soundstar catheter was connected.The soundstar was exchanged twice before it was recognized and the case continued.Also reported during the last 5 minutes of the procedure an intermittent chest patch sensor error appeared (code unknown but could have been 397) on the carto 3 system.The flouroscopic image intensifier was raised, no metal in the field was confirmed, but no further troubleshooting was performed.They believed that the yellow chest patch sensor cable was going bad.Additional information was received on the event.The adverse event was discovered during use of biosense webster products.Intervention was a review with soundstar and transthoracic probe.Patient outcome of the adverse event was improved.A transseptal puncture was not performed.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of a steam pop.The event was noticed post ablation in the right atrium.Irrigated catheter was used and the flow setting: stsf settings.Force visualization features used: graph, dashboard, vector & visitag with the visitag module parameters for stability: 3mm, 3 seconds, 25% 3 gs with no additional filters.The carto recognition issue was assessed as not mdr reportable.The device cannot be recognized by the carto system, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The ultrasound recognition issue was assessed as not mdr reportable.The incidence of catheter /ultrasound recognition issue is easily detectable by the user.This issue usually occurs during routine procedure setup and would result in a pre- or intra-procedural delay.If pre- or intra- procedural delay occurs, this has either no or low impact to patient safety as the patient is not subjected to any procedure/ intervention and their premorbid status remains unchanged.The c-3 location patch issue was assessed as not mdr reportable.This is highly detectable.Most likely harm is procedure delay or cancellation.The adverse event was assessed as mdr reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 25-nov-2021, case analysis was done of the carto®3 system data provided from the case to confirm findings and determine any potential failures in device or operation.No device failure was found from the carto®3 analysis.Esophageal injury is a known risk of rf ablation on the posterior wall.To reduce risk of esophageal injury while ablating on the posterior wall, users are instructed to reduce power force and duration of ablation.Additionally, we encourage users to use various methods of esophagus visualization.It is agreed that the cause of the event is procedure related.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12972962
• MDR Text Key: 286255368
• Report Number: 2029046-2021-02147
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; NON BWI-SIEMENS ULTRASOUND SYSTEM.; SOUNDSTAR ECO SMS 8F CATHETER.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.; UNK_SOUNDSTAR.
• Patient Outcome(s): Life Threatening
• Patient Sex: Male