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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Fistula (1862)

Event Date 05/31/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient developed an atrioesophageal fistula and air embolism requiring surgery.It was reported that atrioesophageal fistula was discovered after afib ablation procedure done on may 31st.According to physician, it was difficult to isolate left inferior pulmonary vein, so it was ablated a lot on the posterior wall.Patient now in stable condition.Initially it was not thought of a fistula, when patient vomited blood, the patient received gastroscopy, which led to cerebral air embolism.When finally, the fistula was diagnosed, it was treated with a chronic total occlusion (cto) clip.

Manufacturer Narrative

Device investigation details: available information indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Manufacturer Narrative

On 11-aug-2023, additional information was received indicating the adverse event was discovered post use of biosense webster inc products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The patient¿s outcome of the adverse event was reported as improved.Patient required extended hospitalization because of the adverse event since he was coughing blood and had a cerebral air embolism and paresis due to the diagnostic procedures performed.A stockert smartablate generator was used in this case in power control mode and the correct catheter settings selected on the generator.The pump was switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features were used included dashboard, vector and visitag.Color options used were tag index.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17418939
• MDR Text Key: 320138483
• Report Number: 2029046-2023-01626
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; UNKNOWN PUMP; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening