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

Model Number M490007

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); Fistula (1862)

Event Date 09/13/2019

Event Type  Death  

Manufacturer Narrative

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.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: (1) mfr # 2029046-2019-03823 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2019-03824 for product code m490007 (smartablate¿ system rf generator).

Event Description

It was reported that a (b)(6) year old male patient underwent a paroxysmal atrial fibrilation (afib) ablation on (b)(6) 2019 with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator developed an esophageal fistula and suffered death.It was reported that the patient underwent a paroxysmal afib ablation procedure on (b)(6) 2019.Post procedure the patient developed an esophageal fistula.On (b)(6) 2019, the patient was admitted to the emergency room (er) and the esophageal fistula was diagnosed.The patient subsequently expired on (b)(6) 2019.On 10/14/19 biosense webster inc.Received additional information about the paroxysmal atrial fibrilation (afib) ablation procedure on (b)(6) 2019.It was reported that there was nothing unusual during the procedure.They used an esotest esophageal monitoring probe and it is not unusual to have temperature rise as the physician will immediately come off ablation and wait to ablate again when it cools down.On 10/24/19 biosense webster inc.Received additional information indicating the adverse event was discovered after the use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The event required surgical repair of the esophageal fistula.Pre-procedure the patient¿s diagnosis was paroxysmal afib.The generator used during procedure was a smartablate generator (sn: (b)(4)).No servicing was requested for the generator.The overall time (minutes and seconds) for ablation at the site of injury is unknown.The smartablate generator parameters were power control mode, 20 watts with a 37c degrees cutoff.No error messages observed on any biosense webster equipment during the procedure.Esophageal probe was used to monitor the temperature during the ablation of the posterior wall.The thermocool® smart touch® sf bi-directional navigation catheter was not in close proximity to another catheter.The catheter was zeroed after the initial warm-up phase post connection to the carto® 3 piu.The force visualization features that were used were graphy, dashboard, vector and visitag.The visitag module was used with the following stability settings: 2mm/3 secs, fot 25% 5gr, and tag index.In summary, esophageal fistula was discovered three weeks post procedure and the patient had expired despite surgical intervention.During the procedure esophageal probe, reduced power (20 watts) on the posterior wall and 37 degrees cut off were used.The force was monitored using the visitag module that was used.There is no indication that any system malfunction had contributed to the event, however, based on the provided information the involvement of bwi products cannot be excluded.

Manufacturer Narrative

It was reported that a 49-year-old male patient underwent a paroxysmal atrial fibrilation (afib) ablation on (b)(6)2019 with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator developed an esophageal fistula and suffered death.It was reported that the patient underwent a paroxysmal afib ablation procedure on (b)(6)2019.Post procedure the patient developed an esophageal fistula.On (b)(6)2019 , the patient was admitted to the emergency room (er) and the esophageal fistula was diagnosed.The patient subsequently expired on 10/5/2019.In summary, esophageal fistula was discovered three weeks post procedure and the patient had expired despite surgical intervention.During the procedure esophageal probe, reduced power (20 watts) on the posterior wall and 37 degrees cut off were used.The force was monitored using the visitag module that was used.There is no indication that any system malfunction had contributed to the event, however, based on the provided information the involvement of bwi products cannot be excluded.Device investigation details: the device investigation has been completed.Upon follow-up with the customer, the service for the smartablate¿ system rf generator was declined because servicing was not needed for the unit.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.Since service was declined, system malfunctions could not be confirmed.Manufacturer¿s ref # pc-(b)(4).

• 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
• MDR Report Key: 9250977
• MDR Text Key: 164134612
• Report Number: 2029046-2019-03824
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ESOTEST ESOPHAGEAL MONITORING PROBE; THMCL SMTCH SF BID, TC, D-F; ESOTEST ESOPHAGEAL MONITORING PROBE; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 49 YR