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 Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 10/11/2022

Event Type  Death  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).

Event Description

It was reported that a male patient born in the (b)(6) (patient was also reported to be in their 70¿s) underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis, cpr, and ultimately death.It was reported that during the isvt ablation on (b)(6) 2022, the right ventricle was perforated, a pericardial effusion occurred, and after much intervention, the patient ultimately expired.The series of events were as follows: the physician was monitoring the patient's heart with intracardiac echo (ice) while ablating.Pericardial and left ventricle (lv) fluid was noticed.The physician stopped ablation and a pericardiocentesis was performed.The physician could not withdraw blood out, was restricted.Protamine was administered during the pericardiocentesis.The patient's blood pressure dropped dramatically.A transesophageal echo (tee) was performed, and it was noted that there was "clot¿ recognition.Cardiopulmonary resuscitation (cpr) was administered for thirty minutes which improved profusion.Pharmacologic agents were also administered, including epi.The patient did not recover and expired.The patient history included: recent stemi (st elevation myocardial infarction) and drug eluding stents placed, both on (b)(6) 2022.The biosense webster inc.(bwi) catheter in use was a thermocool® smart touch® sf bi-directional navigation catheter (stsf d/f curve), product code d134805 /lot 30880708l, available for return.It was also reported, that at the beginning of the case, prior to the patient event, when the stsf catheter was first in use, a sensor error (code unknown) occurred on the carto 3 system.The cable was exchanged without resolution.The catheter was exchanged, and the error resolved, the case was continued.In the physician¿s opinion, the patients cause of death was a combination of cardiac perforation of right ventricle (rv) free wall and left ventricle (lv) filling with fluid.Cpr and pharmaceuticals were provided.A smartablate generator was used (g4c-0103).A transseptal puncture was performed was a baylis veracross rf wire and fixed sheath with baylis nrg transseptal needle.The flow setting was to standard default.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Sensor error on the first ablation catheter into the body pre-ablation was noted above.Graph force visualization features was used.Parameters for stability used with visitag were surpoint settings: 3,3,3 25%.Respiration adjustment additional filter was used with visitag.Impedance color option was used prospectively.The magnetic sensor failed pre-ablation, therefore information on temperature or generator not applicable.Follow up was done to clarify the reported event that clot was recognized and to request more information on lv filling.The response received was that the information is unknown.Thrombosis will be conservatively reported.Should additional information become available this complaint will be reassessed accordingly.All deaths where bwi fda approved ¿ ce mark devices are involved are reportable.The magnetic sensor error issue is not mdr reportable.The incidence of magnetic sensor error is easy detectable by the user.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.

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2022.It was reported that a male patient born in the 1940¿s (patient was also reported to be in their 70¿s) underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis, cpr, and ultimately death.It was reported that during the isvt ablation on (b)(6) 2022, the right ventricle was perforated, a pericardial effusion occurred, and after much intervention, the patient ultimately expired.The series of events were as follows: the physician was monitoring the patient's heart with intracardiac echo (ice) while ablating.Pericardial and left ventricle (lv) fluid was noticed.The physician stopped ablation and a pericardiocentesis was performed.The physician could not withdraw blood out, was restricted.Protamine was administered during the pericardiocentesis.The patient's blood pressure dropped dramatically.A transesophageal echo (tee) was performed, and it was noted that there was "clot¿ recognition.Cardiopulmonary resuscitation (cpr) was administered for thirty minutes which improved profusion.Pharmacologic agents were also administered, including epi.The patient did not recover and expired.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.A screening test was performed, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.The temperature and electrical were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30880708l number, and no internal actions related to the complaint were found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Biosense webster¿s quality process ensures all devices are manufactured, inspected, and released to approved specifications.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: 15749488
• MDR Text Key: 303214487
• Report Number: 2029046-2022-02770
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30880708L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/12/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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: SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, D-F; UKN BRAND CABLE; UNK BAYLIS NRG TRANSSEPTAL NEEDLE; UNK BAYLIS VERSACROSS RF WIRE AND FIXED SHEATH; UNK BRAND CABLE; UNK_CARTO 3
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Sex: Male