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

Catalog Number SEE H10.

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: field d4.Catalog should be ¿unk_smart touch bidirectional sf¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required medication, chest compressions and prolonged hospitalization.It was reported that during the pvc procedure, they noticed the patient's blood pressure dropped after they got into the epicardial.They used transthoracic echocardiogram (tee) and were able to confirm a pericardial effusion had been sustained by the patient.The patient was then provided with chest compressions and medication, and they stabilized after a little bit of monitoring.Patient left the lab stable without additional intervention or surgery.The patient was hospitalized for observation for 1 day post procedure.Th physician's opinion on the cause of this adverse event is that it was procedure related and occurred during use of bwi products.The effusion occurred when they were getting access to the epicardial.Although physician reported the effusion was caused during epicardial access, we cannot exclude the possibility of bwi ablation catheter contributing to adverse event as the ablation catheter was used in the right ventricle.The patient¿s outcome from the adverse event was reported as improved.It was reported the thermocool® smart touch® sf bi-directional navigation catheter was used in the right ventricle.Force visualization features used included graph, dashboard, vector and visitag.Paremeters for stability used were respiratory gated, max distance @ 3mm, min time @ 3s, force over time (fot) of 25% at 3g.Color options used were time (3 to 15 seconds).

Manufacturer Narrative

On 3-oct-2023, additional information was received indicating the patient suffered cardiac arrest and a pericardiocentesis was performed.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17693403
• MDR Text Key: 322769240
• Report Number: 2029046-2023-02012
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/16/2023
• 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.; OPTRELL, 48 ELECTRODES, D-F.; UNKNOWN DECANAV CATHETER.; UNK_SOUNDSTAR.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female