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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: a picture was received from the customer to aid in the investigation.Evaluation was performed following biosense webster's procedures.According to the pictures provided by the customer, char was observed on tip.A manufacturing record evaluation was performed, and no internal action related to the reported complaint were identified.Char is a physical phenomenon of radiofrequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis, and a root cause cannot be assigned based on the current evidence.If the device is received, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: e1.Initial reporter phone: (b)(6).Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus/clot issue occurred.It was reported that 20 minutes after catheter insertion, and 10 minutes after starting the ablation, when conducting ablation at the left bottom, there was a slight strange sensation.When looked at the tip of the catheter, a very small amount of thrombus adhered, and it was able to be wiped off.Irrigation flush was performed, but irrigation was able to be normally performed.There was no problem with high flow and there were no other problems.It was suggested to the physician to replace the catheter, but since there was no other problem, he continued to use the same catheter because only several ablations were left, and the procedure was continued as was.Three ablations were conducted, and the procedure was completed.The physician felt a strange sensation again during right pulmonary vein (rpv) ablation, and the impedance did not increase very much even when the myocardium was contacted.Then, an exceptionally large thrombus was attached to the catheter tip.Activated clotting time (act) value was 270 to 350, and char was also attached to the tip when removing the catheter from the patient's body.After identification of an extra-large thrombus, blood removal of the sheath was carefully performed and thrombus was checked using soundstar, but no thrombus was found in the vacuum.The patient was awake with no paralysis, no deviation from neurological findings such as abnormal pupils, and no dyspnea.Initial postoperative echography showed no pulmonary vein thrombosis.It was also reported the physician noticed the event by uncomfortable feeling of the catheter, no increase in impedance when the catheter touched the cardiac wall.There were no problems with temperature, resistance value, and irrigation.Ablation time did not exceed 60 seconds (per ablation).Around 30 seconds.Total ablation time around 30 seconds.Mean cf value did not exceed 25 g.5~15g.Irrigation setting was within the recommended range.The setting of pre rf time and post rf time: pre 1 second post 1 second.The char was attached to the catheter¿s tip.Set power: basic 30 w, only two ablations on the posterior wall 50 w for 7 seconds.

Manufacturer Narrative

On 12-apr-2023, additional information was received indicating the generator was set to power control mode.Power; basic 30w, but 50w 7sec for only two ablations on the posterior wall.Activated clotting time (act) was maintained in 270 to 350.Duration of ablation was not greater than 120 seconds.No neurological symptom occurred since the procedure was completed.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 18-may-2023, additional information about the event was received.It was indicated there were no error messages observed during the procedure.No abnormalities were found with irrigation, either.Sap and sag were no problem on the routine inspection on april.The physician commented he felt unpleasant sensation with catheter manipulation.There were no issues related to temperature.The smartablate generator was used in power control mode.Impedance:250-50, spike off, temperature: warning:37, cut off 40.Temperature: around 23, impedance:90-120.The correct catheter settings were selected on the generator and the smartablate pump was switching from ¿low¿ to ¿high¿ flow during ablation.The duration of ablation was around 30 seconds in total, none over 60.The contact force was 5-15g, none over 40g.Irrigation was used outside of the prescribed.Normal saline 1000ml + heparin 5000 units.Pre rf time: 1 sec.Post rf time: 1 sec.Visitag modules used with the following settings, respiration setting: yes, stability range:3, stability time:3, force over time:3g, 25%, tag size:2.Color options were - 400-450.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 9-jun-2023, it was noticed the following information was inadvertently omitted from section h10.Additional manufacturer narrative of the 3500a supplemental (follow-up) #2: ¿device evaluation details: on 17-may-2023, the device was returned to biosense webster inc (bwi) for evaluation.The evaluation has been completed.A visual inspection, cool flow pump, and temperature and impedance test of the returned device were performed in accordance with bwi procedures.According to the pictures provided by the customer, char was observed on the tip, however during the analysis in the lab, the device was visually inspected, and it was found in good condition, no char or thrombus/clot attached to the device's tip was observed.A temperature and impedance test was performed, and no issues were observed.A coolflow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The instructions for use contain the following guideline: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.In addition, flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.¿ corrections: the g3.Date received by manufacturer date of the 3500a supplemental mdr # 2 was reported as 18-may-2023 but it should have been 17-may-2023.

• 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: 16637299
• MDR Text Key: 312510634
• Report Number: 2029046-2023-00672
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30940435L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 05/18/2023; 06/09/2023
• Supplement Dates FDA Received: 05/09/2023; 06/08/2023; 06/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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: CARTO 3 SYSTEM.; SMARTABLATE GEN. KIT (JAPAN).; SMARTABLATE PUMP KIT (JAPAN).