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

Model Number D134801

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

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter.There was char and thrombus.It was reported that there was no error codes.Lpv (left pulmonary vein), rpv (right pulmonary vein), and box ablation were performed, and gap map was performed, but many gaps were detected.Because bubble error occurred before additional ablation, a large amount of char and thrombus were found when the ablation catheter was taken from the patient¿s body during performing flush.When the char and the thrombus were removed and the ablation catheter was used again at the physician's discretion, the impedance temporarily decreased after the start of ablation, but gradually increased thereafter.The increased impedance value was about 20 ohms.Flush was performed again, but the same phenomenon reoccurred.Therefore, the ablation catheter was replaced, and improved.Timing when complaints occurred was 1 hour and 46 minutes after use of the catheter.At the time of the ablation in the gap site.Catheter was replaced and this resolved the issue.Ablation time did not exceed 60 seconds (per ablation).Ablation time did not exceed 120 seconds (per ablation).Mean cf value was exceeded 25 g temporarily, but it was extremely momentary.Mean cf value did not exceed 40 g.Irrigation setting was within the recommended range.Set power: back of eso 50 w, roof 40 w, ridge carina 45 w, bottom, posterior wall 35 w, and rpv anterior wall 45 w.The physician's opinions on the relationship between the event and the product was that the event was caused by the catheter¿s malfunction.There were no abnormalities observed prior to and during use of the product.The patient was discharged from the hospital without any abnormalities after the procedure.The physician stated that the defective of the catheter was unavoidable, but elevation of impedance due to char was not prominent, and the physician noticed the char event late (the char event was noticed when taking the catheter out of the patient¿s body).Additionally, the medical team confirmed the ablation never continued beyond the cut-off value.The ablation catheter will be returned for analysis.Irrigation rate used was not outside of those prescribed (power up to 30 w, high flow rate of 8 ml/min; 31 w or greater, high flow rate of 15 ml/min).Carto visitag module was used with the following settings: dashboard; vector; visitag.Color option was tag index.Char is not mdr-reportable.Thrombus/clot is mdr-reportable.

Manufacturer Narrative

On 1-mar-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter.There was char and thrombus.It was reported that there was no error codes.Lpv (left pulmonary vein), rpv (right pulmonary vein), and box ablation were performed, and gap map was performed, but many gaps were detected.Because bubble error occurred before additional ablation, a large amount of char and thrombus were found when the ablation catheter was taken from the patient¿s body during performing flush.When the char and the thrombus were removed and the ablation catheter was used again at the physician's discretion, the impedance temporarily decreased after the start of ablation, but gradually increased thereafter.The increased impedance value was about 20 ohms.Flush was performed again, but the same phenomenon reoccurred.Therefore, the ablation catheter was replaced, and improved.Timing when complaints occurred was 1 hour and 46 minutes after use of the catheter.At the time of the ablation in the gap site.Catheter was replaced and this resolved the issue.Device evaluation details: visual analysis revealed no damage or anomalies on the device.No char was found.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.The cool flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device [30939966l] number, and no internal actions elated to the reported complaint condition were identified.  the char and thrombus/clot issues 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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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

On 12-apr-2023, bwi received additional information regarding the event.Service is not required for the smartablate pump system.The root cause was not identified but likely the returned product (thermocool smarttouch sf) was the root cause.The issue was resolved by replacement of thermocool smarttouch sf.Repair service of the pump system has not been performed because the issue was resolved by replacement of thermocool smarttouch sf.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: 16438554
• MDR Text Key: 310366818
• Report Number: 2029046-2023-00377
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30939966L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2023
• 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; CARTO VISITAG MODULE; OCTARAY CATHETER; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 69 KG