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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Tachycardia (2095); Cardiac Tamponade (2226)

Event Date 11/10/2021

Event Type  Death  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30526911l number, and no internal action 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).

Event Description

It was reported that a (b)(6) year-old male patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a myocardial infarction, ventricular tachycardia and cardiac tamponade requiring a pericardiocentesis and death.A tamponade in the left ventricle has occurred during the ablation, which has led to a rapid drop in the patient's tension, which has not been able to stabilize although it has been carried out various pericardiocentesis.The surgery was delayed due to the reported event.The procedure was not successfully completed.Previous myocardial infarction.In physician¿s opinion, what was the cause of death: patient condition and complications during procedure.Details about the death event: a tamponade in the left ventricle has occurred during the ablation, which has led to a rapid drop in the patient's tension, which has not been able to stabilize although it has been carried out various pericardiocentesis.Force visualization features used: graph, dashboard, vector & visitag with the visitag module parameters for stability: maximum distance change : 3mm, minimum time: 3 s, force over time: 25 % & minimum force: 3 g with respiration adjustment, tag index enable and coloring threshold: low 400, high 500.During ablation, in the reading dashboard was displayed all the time the next parameters: time, power, temperature, impedance, force, stability and ablation index.This adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the patient¿s condition.The patient had suffered a myocardial infarction and was consequently hospitalized on the ward.During hospitalization, the patient had suffered several episodes of ventricular tachycardia.A transseptal puncture was performed with a st.Jude products: agilis nxt, brk1 and sl0.Constant ct measurements were made before ablation.No evidence of steam pop.The event occurred during the ablation phase.Irrigated catheter was used in the event and the flow setting: was 8-15 ml.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.At the end of the procedure, appeared a screen message ¿leakage current has been detected¿.In this moment, we had one a quadripolar catheter located in the right ventricle.We were stimulating for this catheter.The error appeared while the clinical staff practiced the recovery maneuver (pcr).The adverse event was assessed as mdr reportable.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.The current leakage-device disruption issue was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.

Manufacturer Narrative

Additional information was received providing the physician information.Therefore, updated ¿e.Initial reporter¿ section.E1.Initial reporter phone: (b)(6).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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12979101
• MDR Text Key: 282089581
• Report Number: 2029046-2021-02153
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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 Expiration Date: 03/18/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30526911L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: FIXED 6FR,4POLES,A,10PN,115CM.; NON BWI-ST. JUDE AGILIS NXT, BRK1.; NON BWI-ST. JUDE SL0.; PENTARAY NAV ECO 7FR, D, 4-4-4.; SMARTABLATE GENERATOR KIT-WW.; UNKNOWN BRAND PUMP.; UNK_CARTO 3.
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male