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

Model Number D134804

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

Patient Problem Pericardial Effusion (3271)

Event Date 11/08/2021

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.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a female patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient died the day after the procedure.It was reported that a small baseline pericardial effusion was noted pre-procedure via ultrasound and was confirmed unchanged after the afib procedure was completed on (b)(6) 2021.The case was completed without incident.The cas was notified today that the patient expired on (b)(6) 2021.No details were known at the time of the call.All products were disposed of on (b)(6) 2021.Physician¿s opinion on the cause of death: unaware of physician¿s opinion on cause of death.No adverse events during procedure.This adverse event was discovered post use of biosense webster products.Post use.Death was made aware day after date of procedure.Intervention provided was unknown.It is unknown if the patient required extended hospitalization because of the adverse event.A transseptal puncture was performed with a brk.Prior to noting the pe or ct ablation was performed.There was no evidence of steam pop.An irrigated catheter was used in the event, what was the flow setting: stsf settings.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used: graph, dashboard, vector and visitag with surpoint settings and no additional filter used with the visitag.Conservatively this will be reportable.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12897895
• MDR Text Key: 281437394
• Report Number: 2029046-2021-02084
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2021
• 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: BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; VISITAG MODULE
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Sex: Female