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 Cardiac Arrest (1762)

Event Date 02/09/2023

Event Type  Death  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient had pulseless electrical activity (pea) requiring cpr.The patient later passed away.It was reported that a patient death had occurred.They stated that the patient came in for a premature ventricular contraction ablation.The physician mapped the right ventricular outflow track with the ablation catheter.Ablation was performed and the pvcs changed.The bwi representative then remapped the right ventricular outflow tract (rvot).They stated that he noticed noise on the body surface ekgs but the issue resolved on it's own.During the remap process, they noted that anesthesia noticed the patient's heart rate was dropping.The anesthesia then told them the patient was in "pea" (pulseless electrical activity).The physician then opened a stryker acunav intracardiac echo catheter.The physician noted no effusion at that time could be seen.The staff then performed compressions on the patient.The physician called for the ultrasound echo team to come evaluate the patient.The cardiac echo team noted a very small effusion.The physician then performed a pericardiocentesis procedure.No fluid was able to be removed from the patient's pericardial space.The code was resumed but unfortunately the patient expired.Max wattage used: 40 watts ;total lesion: 4 ;total ablation time: 3 minutes 12 seconds ;total fluid: 259 ml.Other bwi products: no.The adverse event was discovered intraop.Physician did not have an opinion on cause.Outcome of the adverse event was death.Transseptal puncture was not performed.The event occurred during post ablation of rvot.The flow setting of the irrigated catheter was high flow 15 ml/min.No error messages observed on biosense webster equipment during the procedure.The force visualization features used are the dashboard, vector and visitag.Parameters for stability for the visitag module used was 3 mm , 3 seconds, 25% and 3 grams.Additional filter used with the visitag was surpoint and tag index.Color options used prospectively was tag index.Additional information was received: details of the death: after the last ablation, it was decided to remap.After setting up the map they noticed the body surface ekg had a lot of noise noted on all leads.While checking the patches the noise resolved on its own.Before they could remap it was noticed that the pvcs were gone.Right after that the physician noticed the rate was slower.Anesthesia then noticed that the patient stopped breathing.While anesthesia was addressing the patient¿s airway the physician stated they were in pea.That is when compressions were started, and the code was called.The physician inserted an intracardiac echocardiography (ice) catheter.No effusion was visualized.He asked for an echo to compare images.They were not sure if they noticed an effusion or not.The rest was correct.The max wattage, total lesions, time, fluid, and other bwi products were correct.They were not sure if there was a pericardial effusion or cardiac tamponade noted.Stst was selected on the smartablate generator.The pump was correctly switching from low to high during ablation.Graph, dashboard, vector, and visitag were all used.Parameters were the standard 3mm for 3sec, 25% and 3 grams along with respiratory gating.

Manufacturer Narrative

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).

Manufacturer Narrative

Additional information was received on 08-mar-2023.Noise was noted on all body surface channels on both the carto and cardiolab.Anesthesia was also connected to the patient with defibrillator pads, but they do not know if they experienced noise at that time.Additional information was received on 23-mar-2023.They did not request servicing of the system and they did not replace the body surface ekg cable.They do not have the serial number for the ukn carto.The only other catheter that was opened was a stryker acunav after the patient started to code.Therefore, updated d10.Concomitant medical products and therapy dates field.The product investigation was completed on 17-mar-2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30917145l and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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; 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: 16507178
• MDR Text Key: 310946769
• Report Number: 2029046-2023-00497
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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
• Device Lot Number: 30917145L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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: STRYKER ACUNAV INTRACARDIAC ECHO CATHETER.; UNKNOWN BRAND PUMP.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 85 YR
• Patient Sex: Male