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

Model Number D134805

Device Problems Insufficient Cooling (1130); Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.Initially abnormal temperature value after connecting the thermocool® smart touch® sf bi-directional navigation catheter (varying from 20 to 60 degree).Noise on all signals (ecg and intracardiac signals on both the patient interface unit (piu) and ep recording system).We also had a leakage current error.Unplugged all cables, restarted the piu, then changed the cable and finally change the catheter.All these problems disappeared when the ablation catheter was unplugged.No ablation was performed with this catheter.Surgery was delayed by 2 minutes.The procedure was completed successfully.No patient consequence reported.Additional information was received on 15-apr-2023.No ablation was performed with this catheter.Noise was observed for all signals.The noise was observed on all systems.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm, but there was no problem when the ablation catheter was unplugged so noises appeared just a few minutes when the catheter was connected (we quickly changed it) the ecg was still readable.During the signal interference, the affected catheter was inside the patient¿s body.This event was originally considered non-reportable, however, bwi became aware of the physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm on (b)(6) 2023 and have reassessed the event as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 25-apr-2023.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.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).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Abnormal temperature value after connecting the thermocool® smart touch® sf bi-directional navigation catheter (varying from 20 to 60 degree).Noise on all signals (ecg and intracardiac signals on both the patient interface unit (piu) and ep recording system).We also had a leakage current error.Unplugged all cables, restarted the piu, then changed the cable and finally change the catheter.All these problems disappeared when the ablation catheter was unplugged.No ablation was performed with this catheter.Surgery was delayed by 2 minutes.The procedure was completed successfully.No patient consequence reported.Additional information was received.No ablation was performed with this catheter.Noise was observed for all signals.The noise was observed on all systems.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm, but there was no problem when the ablation catheter was unplugged so noises appeared just a few minutes when the catheter was connected (we quickly changed it) the ecg was still readable.During the signal interference, the affected catheter was inside the patient¿s body.The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature, impedance, cool flow pump, pressure gauge, electrical and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues or current leakage were observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A cool flow pump and pressure gauge test were performed, and the device was irrigating correctly.No irrigation issues were observed.The 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.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.In relation with the temperature issue, the instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.Flush the catheter with heparinized saline before insertion into the body.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).

• 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: 16928211
• MDR Text Key: 315928346
• Report Number: 2029046-2023-01022
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2023
• 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: 30934485L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• 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