MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMARTABLATE GENERATOR

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

Patient Problems Death (1802); Fistula (1862)

Event Date 02/07/2019

Event Type  Death  

Manufacturer Narrative

Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.The manufacturing record evaluation (mre) cannot be conducted because no serial number was provided by the customer.Concomitant product: carto system, us catalog #: unknown, serial #: unknown.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch¿ electrophysiology catheter and smartablate¿ system rf generator and suffered esophageal fistula (requiring surgical intervention) and cerebrovascular accident (cva) that led to death.The ablation procedure was successfully completed on (b)(6) 2018.No immediate patient consequences were reported.On (b)(6) 2019, the patient was admitted to the emergency department febrile and unable to move two or more limbs and fever.The patient was moved to the intensive care unit (icu).Ct scan was performed which confirmed cva and air in the left atrium.Patient underwent a surgical intervention for esophageal fistula repair on (b)(6) 2019.Post-surgery, the patient was without brain function.The patient¿s family withdrew life support sometime after the surgery and the patient expired.Date of death is unknown.No specific equipment failure occurred during the procedure.Physician¿s opinion regarding the cause of the adverse event is that it was procedure/equipment related.Physician stated the cause of death was the atrioesophageal fistula.Esophageal probe was used as modality to prevent esophageal fistula.The force visualization features used included dashboard, graph taken from ct, vector and visitag.The parameters for stability used with the visitag module were 1.5 mm 10 sec.50% at 5 grams.No additional filter was used with the visitag.The color options used prospectively included time for grid and impedance drop for visitags.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8415384
• MDR Text Key: 138629367
• Report Number: 2029046-2019-02797
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE GENERATOR
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 62 YR