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

Catalog Number D134700

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

Patient Problems Stroke/CVA (1770); Death (1802); Fistula (1862); Sepsis (2067)

Event Date 11/11/2018

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.Concomitant products: carto 3 system, us catalog #: unknown, serial #: unknown.Smartablate pump : us catalog #: m490008, serial #: (b)(4).Lasso navigational catheter, us catalog #: unknown, lot #: unknown.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.(b)(4).

Event Description

It was reported that a (b)(6) year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a smartablate¿ system rf generator and suffered a cerebrovascular accident (cva), sepsis, esophageal fistula and death.The patient had the ablation procedure in (b)(6) 2018.The procedure was completed successfully with no immediate consequences.Post-procedure, the patient presented to the hospital with cva symptoms, high bacteria count and sepsis.No medical/surgical intervention was provided.The patient died on (b)(6) 2019.Autopsy report revealed esophageal fistula.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.No error messages were observed on any biosense webster inc.Equipment during the procedure.The generator was used in power control mode at 50 watts.The overall time for ablation at the site of the injury was 10 seconds approximately.The last ablation cycle time at the site of the injury was 5 seconds.Esophagus temperature monitoring was used as modality to prevent esophageal injury.No excessive esophageal temperature increases were noticed during the procedure.No excessive burnings were applied in any spot on the posterior wall.The physician burned a little more than usual near right superior pulmonary vein (rspv); however, per the autopsy report, the esophageal fistula was located near left pulmonary veins.The force visualization features used included graph, dashboard and vector.The parameters for stability used with the visitag module were 3mm, 3 seconds.No additional filter was used with the visitag.The color option used prospectively was time.The thermocool® smart touch® sf uni-directional navigation catheter was in close proximity to the lasso navigational catheter which was positioned in left superior pulmonary vein (lspv) and it was zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit (piu).The carto 3 system did not indicate to re-zero the catheter.It was stated that no service was needed for the smartablate¿ system rf generator.The patient consequences of "cerebrovascular accident", ¿sepsis¿, ¿esophageal fistula,¿ and ¿death¿ were assessed as reportable under the thermocool® smart touch® sf uni-directional navigation catheter.The patient consequences of ¿esophageal fistula¿ and ¿death¿ were assessed as reportable under smartablate¿ system rf generator.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8318196
• MDR Text Key: 135488951
• Report Number: 2029046-2019-02666
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• 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; Other
• Patient Age: 68 YR