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

Catalog Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 02/01/2024

Event Type  Death  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation which included the use of a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac perforation that required pericardiocentesis and surgical intervention.Patient also experienced cardiac arrest that required cpr, and ultimately, the patient passed away.During an idvt case, a pericardial effusion, and an injury to their right ventricular outflow tract (rvot) that required open heart repair by a cardiac surgeon occurred.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by intracardiac echo.The medical intervention provided was a pericardiocentesis and 2.3 liters of blood was removed.The patient "received blood" with an unknown amount.The patient had open heart surgery and cardiopulmonary resuscitation (cpr) was performed for 45 minutes.The patient was reported to be alive at the time and was in recovery in the cardiovascular intensive care unit (cvicu).Additional information was received.It was reported that steam pop was heard during ablation.The physician came off of ablation immediately and confirmed effusion with abbott viewflex catheter.The physician was burning at 50w with an average force of 19g and cath temp of 24 degrees.Tamponade injury to their rvot caused excessive bleeding.The physician was unsure about the cause of the adverse event.He does not believe it was a result of a biosense webster inc.(bwi) product malfunction.There were no significant lab results pre-procedure.The patient was not on anticoagulants.No significant medical history was noted on the chart.The patient had an extended hospital stay as a result of needing an open-heart surgery to repair the heart following the steam pop and pericardiocentesis.The patient ultimately passed away.

Manufacturer Narrative

B2.Date of death is unknown at this time.Therefore, this field was left blank.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 27-feb-2024 which indicated that the physician¿s opinion on the cause of death was complications from the procedure and patient scans showed a stroke and neuro confirmed no brain activity.The date of death was also reported as on (b)(6) 2024.Therefore, b 2.Date of death was updated.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation which included the use of a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac perforation that required pericardiocentesis and surgical intervention.Patient also experienced cardiac arrest that required cpr, and ultimately, the patient passed away.During an idvt case, a pericardial effusion, and an injury to their right ventricular outflow tract (rvot) that required open heart repair by a cardiac surgeon occurred.There was a drop in blood pressure in the patient.The pericardial effusion was confirmed by intracardiac echo.The medical intervention provided was a pericardiocentesis and 2.3 liters of blood was removed.The patient "received blood" with an unknown amount.The patient had open heart surgery and cardiopulmonary resuscitation (cpr) was performed for 45 minutes.The patient was reported to be alive at the time and was in recovery in the cardiovascular intensive care unit (cvicu).Additional information was received.It was reported that steam pop was heard during ablation.The physician came off of ablation immediately and confirmed effusion with abbott viewflex catheter.The physician was burning at 50w with an average force of 19g and cath temp of 24 degrees.Tamponade injury to their rvot caused excessive bleeding.The physician was unsure about the cause of the adverse event.He does not believe it was a result of a biosense webster inc.(bwi) product malfunction.There were no significant lab results pre-procedure.The patient was not on anticoagulants.No significant medical history was noted on the chart.The patient had an extended hospital stay as a result of needing an open-heart surgery to repair the heart following the steam pop and pericardiocentesis.The patient ultimately passed away.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.The temperature values were found within the specifications.A manufacturing record evaluation was performed for the finished device number lot 31200732l and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.No malfunction was observed during the product analysis.In the physician¿s opinion, the cause of death was complications from the procedure.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.As part of biosense webster¿s quality process, 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: 18794009
• MDR Text Key: 336395704
• Report Number: 2029046-2024-00655
• Device Sequence Number: 1
• Product Code: LPB
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31200732L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2023
• 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: ABBOTT VIEW FLEX CATHETER; BOSTON SCIENTIFIC POLARIS CS CATHETER; UNK GENERATOR; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization; Death; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female