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

Catalog Number D132705

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/14/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a redo pulmonary vein isolation (pvi) procedure using thermocool® smart touch¿ bi-directional navigation catheter.The patient experienced cardiac tamponade that required pericardiocentesis.There was a pericardial effusion in the left appendage area during a redo pvi procedure.The veins were isolated but a touch up was needed around the left atrium left carina and the ridge between the left upper pv and the appendage.There was a total of 28 ablations carried out at 50 w with a total ablation time of 8 minutes and 31 seconds.The average impedance for all of the lesions was 136 ohms; however, on the last 3 lesions, the starting impedance was slightly higher at about 150-170 ohms.The last burn was at 50w and lasted only 2 seconds before the smart ablate cut it off as the impedance rose to 255 ohms.It was after this lesion that the consultant checked the patient¿s blood pressure and it had dropped significantly.Pericardial effusion confirmed with intracardiac echocardiography (ice).400 ml of blood was drained.This all occurred during the case.Before the case ended, the patients¿ blood pressure returned to normal.The patient already had an overnight stay arranged prior to the adverse event so the patient is staying overnight in the hospital.Consultant does not think any products were the cause of this event.Additional information was received.A pericardial drain was fitted and 400 ml of blood was drained.Patient fully recovered.The patient stayed overnight for 2 nights.They extended her stay to monitor the effusion to make sure she made a full recovery.Transseptal puncture was performed.Ablation was performed prior to noting pericardial effusion.Irrigated flow settings: less than 30w 17ml, greater than 30w 30ml.Error message on the bwi equipment: high impedance on the lesion that the effusion occurred.The adverse event was discovered during use of the biosense webster, inc.Products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).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.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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 17912144
• MDR Text Key: 325384546
• Report Number: 2029046-2023-02279
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2023
• 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: SMARTABLATE GENERATOR KIT-WW; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female