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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Laceration(s) of Esophagus (2398)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional information received 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 was performed for the finished device 30922783l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and experienced an esophageal fistula.It was reported that there was an adverse event of esophageal neuropathy.As the patient complained of abdominal discomfort, when the physician examined, gastric peristalsis was weakened.The esophageal vagus nerve may have been injured due to the ablation.Timing when complaints occurred was two days after the procedure.The patient's state has not improved and was being followed up with medication at the time of the call.The physician's opinions on the relationship between the event and the product was that since the ablation site and the esophageal temperature sensor were separated enough and no increase in temperature was observed, the ablation was conducted with ai 400 as an indicator.However, there was a possibility that the ablation may have been conducted at the area over the edge of the esophagus.There were no abnormalities observed prior to and during use of the product.The patient has no relevant medical history nor relevant tests/laboratory data.The patient is being followed up with medication.Modalities used to prevent esophageal injury was esophageal temperature monitoring with an esophageal temperature sensor was performed.A sufficient distance between the ablation site and the esophageal temperature sensor was maintained.The physician was careful about the temperature increase and ablation was performed with ai 400 as the index.The esophageal injury was confirmed as the patient complained of abdominal discomfort, when the physician examined, gastric peristalsis was weakened.Endoscopy was performed in addition to medication.The patient's current condition is recovering.The patient was discharged from the hospital on (b)(6) 2023.Extended hospitalization was required for follow-up of the patient.Servicing of generator/pump is not needed.The generator parameter settings are as follows.Power control mode, and temperature cut-off setting was set as default setting.Noted catheter temperature, impedance and power were unknown because it was unclear when the adverse event occurred.The correct catheter setting was selected on the generator.The pump irrigation flow rate setting was normally controlled by the generator without any issues.Carto3 did not instruct re-zero of the catheters during the procedure.Force visualization features used was dashboard; vector; visitag.Additional filter used with the visitag was fot.Color option used prospectively was tag index.Stability parameters of vizitag module are as follows.Range: 3 mm, time: 3 second, fot: 25% tag size 2.

Manufacturer Narrative

Additional information was received on 29-mar-2023.Outcome of the adverse event was improved.A smartablate generator was used.(product code: m4900207.Serial number: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 27-mar-2023, the clinician has re-assessed this event and the code was corrected from esophageal fistula to esophageal ulcer as there was no indication of a fistula, but only of an injury that required medication and prolonged hospitalization.Therefore, the h 6.Health effect - clinical code has been updated.

• 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: 16514200
• MDR Text Key: 311043235
• Report Number: 2029046-2023-00503
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30922783L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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 GEN. KIT (JAPAN); UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 59 KG