MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133600

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

Patient Problems Stroke/CVA (1770); Death (1802); Fistula (1862); No Code Available (3191)

Event Date 02/07/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. the manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(4).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: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 8415372
• MDR Text Key: 138629388
• Report Number: 2029046-2019-02796
• 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: D133600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 62 YR