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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

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.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

It was reported that a patient underwent an atrial fibrialation (afib) ¿ persistent ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a massive stroke.It was reported that after an afib case, the patient suffered a massive stroke.They reported there were no visible signs on the patient during the procedure.They did not have any details on how the stroke was first discovered and whether any medical intervention had to be provided.They stated they were informed today that after the patient suffered a massive stroke, they were unable to follow commands, unable to speak and failed the swallow test.The patient was admitted to the icu at the time of the call.The ablation catheter is not available to return.The adverse event was discovered post use of biosense webster (bwi) products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician had returned to the left atrium (la) after protamine was administered.The bwi representative talked to the physician afterwards and he felt that it may have been the culprit, despite restarting heparin.The physician did not indicate that bwi products could be possible reason for the adverse event.Outcome of the adverse event was improved, regained some function.In rehab.Patient required extended hospitalization because of the adverse event.Other relevant history- prior af ablation in 2018 with no known complications.Generator information was smartablate / m490002 / g4c-0704.There was no evidence of char during the procedure.There was no evidence of blood thrombus/clot during the procedure.Correct catheter settings were selected on the generator.Pump switching was from "low" to "high" flow during ablation.

• 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: 16414753
• MDR Text Key: 309955121
• Report Number: 2029046-2023-00337
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 02/21/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/21/2023
• 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: SMARTABLATE GENERATOR SPARE-US.; UNK_CARTO 3.
• Patient Outcome(s): Hospitalization; Life Threatening