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

Model Number D134805

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/04/2022

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.(b)(4).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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient expired following the afib procedure.It was reported that after an atrial fibrillation case completed on wednesday, (b)(6) 2022, the patient passed away on (b)(6) 2022.The case was completed successfully, with no observed complications or issues during the procedure.Post-ablation the patient had normal sinus rhythm.Before the procedure started, the physician had "revoked the dnr for 24 hours." the biosense webster inc.(bwi) representative reported that they were notified on (b)(6), after the procedure was completed, that the patient was "not doing well," and the patient was transferred to the ccu.They were then notified on (b)(6) 2022, that the patient had passed away.They did not have any other details regarding the events leading up the patient death.The adverse event was discovered post case, while in the pacu.The physician¿s opinion of the cause of the adverse event was that it was due to the patient condition.The bwi representative was not given the information about the intervention used on the patient.The patient outcome of the adverse event was death which was reported to the bwi representative on (b)(6) 2022.The bwi representative was not given the patients¿ medical record, nor was anything stated verbally beyond that the patient was not in good health.The bwi representative was not told the specific cause or details related to patient death.An stsf was used.The physician used artificial intelligence (ai), surpoint visitags, the ablation information he viewed was: force, impedance, time, temp, power, electrogram attenuation, and data from the generator via the recording system.Regarding the coloring of visitags, the physician specifically used ai.Based on their research and reading of european papers published in regard to ai, they stay within parameters outlined as safe and efficacious.All additional filters were used with the visitag.The stsf catheter is not available for return.The lot number is unknown.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14552415
• MDR Text Key: 293055140
• Report Number: 2029046-2022-01158
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Date Manufacturer Received: 05/04/2022
• 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: UNK_CARTO 3
• Patient Outcome(s): Death
• Patient Sex: Male