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

Catalog Number D132705

Device Problems Coagulation in Device or Device Ingredient (1096); Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ischemic Heart Disease (2493)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

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 premature ventricular complex (pvc) ablation with a thermocool® smart touch¿ bi-directional navigation catheter and the patient experienced st elevations, ventricular tachycardia, cardiac arrest that required chest compressions and placement of extracorporeal membrane oxygenation (ecmo).During ablation, the catheter temperature would intermittently display the error "temperature exceeded cut-off".The cut-off temperature was set at 45 degrees celsius.The physician pulled the catheter out of the body and noticed char on the tip of the catheter.The physician removed the char and placed the catheter back into the body.They began mapping around the right ventricular outflow tract (rvot) and the patient's heart rate elevated to 100 beats per minute.They noticed a morphology change and the qrs showed a possible st elevation.The patient reported feeling hot and sweating.The physician requested that the blood pressure be cycled.The patient continued to report that he was not feeling great.The blood pressure then dropped to 100 bpm.The patient then went into ventricular fibrillation and cardiac arrest.The "issue was discovered and confirmed on the recording system for pacing and the recording system for the carto system coupled with the patient's symptoms." the medical intervention provided was chest compressions performed for 45 minutes.The patient was shocked multiple times, and the patient was eventually put on a bypass machine.The physician ordered an echocardiogram and determined that there was no effusion.The patient was stable at the time of reporting and intubated on an ecmo machine.They were about to put in an impella as well.The physician's opinion on the cause of the adverse event was that it was procedure related, char could have restricted flow.The patient required prolonged hospitalization.Temperature cut-off value was indeed exceeded when error message was displayed.The system stopped the ablation when the cut off value was exceeded.Patient was anticoagulated and activated clotting time (act) was roughly 300.The physician did not consider the char as excessive.He wiped off the char and re-inserted the catheter into the body and continued burning.However, the physician considered the amount of char observed could be a potential risk to the patient, as char or prior disease in the arteries could be a cause of coronary clot.The duration of ablation used was greater than 120 seconds, it did not exceed 40g¿s but did exceed 25gs.

Manufacturer Narrative

On (b)(6) 2024, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31087922m 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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 18532535
• MDR Text Key: 333087195
• Report Number: 2029046-2024-00210
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 31087922M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR SPARE-US; UNKNOWN IRRIGATION PUMP; UNKNOWN PACING RECORDING SYSTEM; UNKNOWN RECORDING SYSTEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG