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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone : (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30897746l 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.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 patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cerebrovascular accident.It was notified 17 days post procedure of a stroke event on a patient that had an atrial fibrillation (afib) ablation done on the (b)(6) 2023.During ablation on the left atrium, near the left atrial appendage (laa)/ left superior pulmonary vein (lspv) ridge, they had an impedance cut off warning.Ablation was only on for <20seconds at each attempt to ablate.Baseline impedance was also high in this location.When they moved the catheter to another area of the heart there was no impedance issues and ablation was able to continue.They came back to that area on the superior anterior ridge a couple times (3 or 4 max) and tried to position the catheter differently to ablate there - thinking that maybe they were in a pouch of some sort, but in the end, they had to change strategy to ablate there for isolation of the left veins.The patient was only coagulated to and managed at max act 250.The physician stated they were unable to get them to maintain an act of 300.No trans-oesophageal echocardiogram (toe) was performed prior to the procedure to access smoke or thrombus as the toe doctor was unavailable.They had no alerts on the system for flow and no high impedance anywhere else in the heart.The doctor felt that potentially the catheter developed char in that spot of high impedance that could have dislodged and lead to a stroke event.The doctor is now wary of the catheters for future use.The catheter was operated within the instructions for use (ifu) - heparinized saline was used, 120s ablation time.30w and force below 20g.Additional information was received on 19-mar-2023 and a question was asked if the doctor considered the char /coagulum/thrombus/clot is excessive.The response was ¿no char or clot was observed during the procedure¿ the patient developed facial palsy and slurred speech one hour after procedure upon waking.Scan showed a "showering" event on the brain.The patient was kept in the hospital for 2 weeks due to a restriction on travel and being from tasmania.According to the doctor, the patient has now recovered at 95% norm.Ablation catheter listed for this complaint as the doctor is concerned that it was responsible.Product unavailable for return as the procedure was over 2 weeks ago and have only just been informed.Surgery was not delayed due to the reported event.Procedure was successfully completed.The generator was set to 120 secs but they usually came off at 60secs.However, in the area of interest, they were not able to ablate or only on ablation at max<20s.The force threshold set was a typo - force threshold was set to <40grams.The adverse event was discovered post use of biosense webster products.Stroke was only noted in recovery post procedure.The physician¿s opinion on the cause of this adverse event was a combination of several factors ¿ low act and potentially catheter.Stroke team treated patient for stroke symptoms.The patient mostly recovered and not obvious stroke had occurred.The patient required extended hospitalization because of the adverse event as patient was from tasmania so was unable to fly for 2 weeks as that¿s protocol for a stroke, therefore remained in hospital until they were cleared to fly home.Generator information was a smart ablate generator g4c-0819, smart ablate pump g4cp-0845.The system presented the high impedance cut off at the one spot described in the complaint.There were no issues related to temperature and flow on the catheter.Power mode ¿ 30w.Ablation delivered between 60-120s during entire case.But only max duration of 20s at site of high impedance.The irrigation rate was not used outside of those prescribed.The pre-ablation high setting was 5 seconds only hep-saline fluid used.

• 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: 16684159
• MDR Text Key: 312722206
• Report Number: 2029046-2023-00726
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30897746L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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-WW.; SMARTABLATE PUMP KIT-US.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male