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

Catalog Number D132704

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

Patient Problems Fistula (1862); No Code Available (3191)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a smartablate¿ system rf generator (us) and suffered atrioesophageal fistula requiring surgical intervention.Post procedure and post use of biosense webster, inc.Products, the patient complained of having sub-sternal chest pain.The patient was referred for a chest computed tomography (ct) scan.The scan showed the patient had developed an esophageal fistula and two holes were found below the right pulmonary vein in the left atrium.The patient was taken to another hospital and underwent surgery to repair the esophageal fistula.The physician noted that the patient was in stable condition.The physician¿s opinion on the cause of the adverse event is unknown, however, the physician did not implicate anyone or anything to be the cause.Extended hospitalization was required because the esophageal fistula repair was not successful.At the time of the report, it was noted that the patient was still in the hospital.The outcome of the adverse event is unchanged.There were no error messages displayed on any biosense webster, inc.Equipment.The generator was operating with 50 watts of power, average contact force of 23 g for 34 seconds, average temperature of 23 degrees celsius and impedance of 16 ohm.The modality used to prevent the esophageal fistula was the esophageal temperature probe.The carto® 3 system did not indicate to re-zero the catheter.The force visualization features that were used were graph, dashboard, vector and visitag.The parameters for stability were 2.5mm/3sec.Additional filter that was used was surpoint module and the color options that were used prospectively was surpoint tag index.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• 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 ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9419584
• MDR Text Key: 180632283
• Report Number: 2029046-2019-03960
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 11/13/2019

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 Catalogue Number: D132704
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/05/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR