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

Model Number M490007

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 hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Still pending is the manufactured date.Therefore, a supplemental report will be submitted.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.

Manufacturer Narrative

Investigation summary- it was reported that a 36-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.The device was evaluated, and the secure digital (sd) card was found to be defective.The secure digital (sd) card was reprogrammed, and the issue was resolved.The smartablate¿ system rf generator (us) was also subjected to preventative maintenance (pm), safety and functional testing and all tests passed.The customer complaint was not confirmed for the adverse event.It was confirmed that the secure digital (sd) card was defective, however, the defective secure digital (sd) card could not contribute the adverse event.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference # (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9419617
• MDR Text Key: 180631443
• Report Number: 2029046-2019-03958
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M490007
• Device Catalogue Number: M490007
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; THMCL SMRTTCH,BI,NAV,TC,F-J,C3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR