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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf.The patient experienced hypotension.It was reported that during a procedure there was an adverse event.While performing an rf re-do atrial fibrillation case, the patient's blood pressure dropped, and the patient began to turn blue.They reported that there were no spikes in impedance or force.The physician checked for effusions and found none.The medical intervention performed was the physician shot the coronary veins and the pulmonary arteries.They administered epinephrine and some other medications and pulled both the vizigo sheath and the ablation catheter from the left atrium to the right atrium and monitored the patient.The patient then stabilized, and they took out the ablation catheter.They reported that there was no char and no coagulation.They then pulled out the vizigo sheath and reported that on one side of it, on the "second braiding on the shaft", it appeared that there was some char.The patient was then hooked up to a brain scanner to ensure there was no brain damage.Everything appeared fine.The physician thought it may be an external reaction to something.The physician thought the drop in blood pressure may be attributed to " broken heart syndrome", where the bottom of the heart does not pump as naturally as it should.The patient is currently stable and is being transported to the intensive care unit.The event was confirmed with vital readings.Patient was reported as stable.Lot numbers of ablation catheter and vizigo sheath are not available.The products are available to be returned.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was an external patient issue.Intervention came in a short coronaries and the pulmonary artery¿s then he was stabilized and taken to icu.They also checked how his brain was perfusing.Outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event because his ef (ejection fraction) was still low and they are not sure exactly what happened.Other relevant history- this was a redo cryo ablation.Stockert gmbh smart ablate system sn (b)(6), ref- (b)(4) was used.The char was located on the mid shaft.The system did not present any error messages or did the physician/user see any product problem.They didn¿t see the char until that.Vizigo was out of the body.There were no issues related to temperature and flow on the catheter.Generator parameters- power control mode.Temp 40 c power not sure; ranged.Power was between 20-30 wats temp- was in the 20c imp- 120-150.The patient was anticoagulated, they were not sure the of the physician preference but they were maintained.Stockert gmbh smartablate system ref-(b)(4), sn- (b)(6) was used.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The duration of ablation used was not greater than 60 seconds or greater than 120 seconds.The average contact force was not greater than 40 grams or 25 grams.There was no ablations that used forced above 40 g for any extended periods of time.Irrigation rate was not used outside of those prescribed.Heparinized normal saline was used as the irrigation fluid.Carto visitag module was used, respiratory adjustment checked max distance change- 2 minimum time-3s force over time 25% minimum force 3g tag size 3.Time 5-20sec was used.Char is not 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

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.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: 16854845
• MDR Text Key: 314401788
• Report Number: 2029046-2023-00942
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; SMARTABLATE PUMP; VIZIGO SHEATH
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male