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 Fistula (1862); Cardiac Perforation (2513)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

A request for clarification of the awareness date is being requested.However, no further information has been made available.If additional information is received, a supplemental 3500a report will be submitted to the fda.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) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient experienced esophageal fistula that required surgical intervention and prolonged hospitalization.On (b)(6) 2023, an atrial fibrillation (afib) procedure was being performed under general anesthetic by the physician.All four pulmonary veins were treated using cryoballoon ablation.The decision to isolate the posterior wall was made and an stsf d/f curve ablation catheter was utilized for this.On the first week of january 2024, the biosense webster inc.(bwi) representative was notified that the patient experienced an esophageal fistula.The patient underwent successful surgical repair and remains in recovery at the time of reporting.

Manufacturer Narrative

On 26-mar-2024, based on further discussions between the biosense webster representative and the physician, the patient has been doing well with recovery at home with no further complications post-surgical repair.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).Additional information was received on 16-jan-2024.It was reported that on (b)(6) 2024, the patient reported having shortness of breath and gurgling.The patient was instructed to come into the hospital for a computed tomography (ct) scan and examination.The ct scan on (b)(6) 2024 showed perforation in the left atrium.Surgery was performed on the (b)(6) 2024 to patch the left atrium, no patches on the oesophagus were needed.On 23-jan-2024, additional information was received.The symptoms were formally reported on (b)(6) 2024 when the patient's procedure was on (b)(6) 2023.The physician's opinion on the cause of the adverse event was a combination of ablation therapies that led to pinhole perforation (i.E., radiofrequency (rf) and cryoablation therapies).The patient was reported to be recovering at home on fluid diet.Generator parameters were: power control; 50w, temp warning 37 degrees, cut off 40 degrees c.The noted temperature, impedance, and power at the time of the perforation: temp: 24; impedance: 132 start 117 end of lesion; power: 50 w; force: 12g average; 16.55 sec ablation time.No error messages observed on biosense webster equipment during the procedure.Temp probe placed in the esophagus to prevent esophageal injury.Esophageal injury was confirmed via ct.Section a for patient information was updated based on the additional information received.Section e for initial reporter was updated as the physician¿s name and telephone number were provided.The concomitant product section was updated based on additional information received.H 6.Health effect - clinical code was updated and cardiac perforation (e0604) was added based on the additional information received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 18503509
• MDR Text Key: 332784989
• Report Number: 2029046-2024-00162
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 03/26/2024
• 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: SMARTABLATE GENERATOR KIT-WW; UNK_CARTO 3; UNK_CRYOBALLOON ABLATION CATHETER; UNK_SMARTABLATE GENERATOR CABLE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 135 KG