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

Catalog Number D134702

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

Patient Problem Cardiac Tamponade (2226)

Event Date 08/16/2023

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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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).

Event Description

A patient receiving a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) has died.A pulmonary vein isolation (pvi) radiofrequency (rf) ablation was performed at 50w 10seconds.According to the user, there was probably a steam pop (loud pop sound) at one point, after which the patient's blood pressure dropped shortly thereafter.Pericardial effusion (pe) was detected, and 3 liters of blood was pumped out, patient resuscitated, but all to no avail.The patient passed away at the table on (b)(6) 2023.The biosense webster representative was not present during the index procedure.The nursing staff was present at the carto station.The stsf ablation catheter was thrown away and lot number is not available.The adverse event was discovered during product use.The physician's opinion on the cause of the adverse event was that it was product malfunction related and patient condition of diluted blood.Intervention provided were 2 liters of blood were drawn and administered, then transferred to the intensive care unit (icu) where another 1 liter of blood loss and administered again.The patient expired in ward on the same day.The physician's opinion on the cause of death was steam pop.The physician provided the following details surrounding the patient¿s death.Steam pop occurred during rf ablation in the area of the left atrium (la) roof (with ablation index of 400, stsf catheter, 50 watts) with pericardial tamponade.Last week again in one patient a total of 3 steam pops each at low ablation index around 300 and contact force (cf) of less than 20g, but without pericardial effusion.The last few weeks (the last 6 weeks, as it were), small steam pops were performed from time to time, each time without clinical problems, each time without relevant cf or increased ablation index.In each case, no error messages, or problems in the carto at the time.Visitag module parameters for stability were 3mm, 3s, ablation index of 500 anterior 380 posterior, tag size 3.Additional filter was force over time 25%-3g.Transseptal puncture performed with brk needle (abbott).Flow setting for the stsf catheter was 15ml/min.No errors observed on biosense webster equipment during the procedure.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17750585
• MDR Text Key: 323464648
• Report Number: 2029046-2023-02081
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

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 Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 BRK NEEDLE.; SMARTABLATE GENERATOR KIT-WW.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.; UNK_PENTARAY.
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 107 KG