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 Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was thrombus and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.On (b)(6) 2022, the physician informed that it seemed that a thrombus had formed near the cauterization line of left pulmonary vein (lpv) in the second procedure on (b)(6) 2022.The patient had a cerebral infarction, which was revealed later.The timing the physician noticed the event is unknown.There were no issues related to temperature, resistance or irritation.Ablation time was about 15 to 30 seconds.60 and 120 seconds were not exceeded.The total time energized for this procedure was about 1 hour.The mean contact force (cf) of 25 g was exceeded, and the average cf of 40 g was sometimes exceeding.The irrigation settings were set at the default setting.The pre-radio frequency (rf) time and post-rf time was set at pre-3 seconds, post-5 seconds.The power output was 50 w.The adverse event was discovered post use of biosense webster products.There was no evidence of char during the procedure.It seemed that a thrombus had formed near the ablation line of lpv.But it was unknown if it occurred during the procedure or after the procedure.The thrombus/clot was not attached on the catheter.No error message observed during the procedure.No issue related to the temperature and flow on the catheter.Ablation power setting: pv circumference 50 w, roof and posterior wall 35w.Additional information received on the event.After discharge from mitsubishi kyoto hospital, the patient was found with a cerebral infarction at another hospital.The physician¿s at the mitsubishi kyoto hospital said that did not know the details of the patient condition at the moment.Causal relationship with the product was not known.The physician¿s comment was that since no thrombus or char was observed on the ablation catheter, it was confirmed that the causal relationship between the event and the product was not clearly understood.There was no problem during hospitalization and the patient was discharged as usual.The biosense webster, inc.Representative could not obtain further information because the patient had a cerebral infarction at another hospital.The physician commented that there was no cause that he could think of.The patient is probably hospitalized in another hospital.The patient had no relevant history.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.Char, coagulum, thrombus or clot was not attached on the catheter.The generator was set to power control mode, impedance cut off value was 220o.The patient was anticoagulated and the act was maintained over 300 sec.Heparinized normal saline was used as the irrigation fluid.The carto visitag module was used and the settings were respiration setting: on, stability range: 3mm, stability time: 3sec, force over time: 25%, tag size2 with tag index.

Manufacturer Narrative

Initial reporter phone: (b)(6).The event date was reported as unknown.Therefore, the first day of the year has been entered as the event date.Date of event field.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30749532l 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 4.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).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 08-sep-2022, noted correction to the 3500a initial under the ¿g3.Date received by manufacturer¿ field as it was processed as 11-aug-2022 and it should have been processed to 12-aug-2022.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15380922
• MDR Text Key: 299491911
• Report Number: 2029046-2022-02154
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30749532L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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); SMARTABLATE PUMP KIT (JAPAN); UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male