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

Model Number D134805

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

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

Event Date 11/28/2022

Event Type  malfunction  

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 a bad/no ecg all channels (body surface and intracardiac) issue occurred.Initially the carto 3 system was displaying a current leakage and all body surface electrograms disappeared.To troubleshoot, the cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.The current leakage issue was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.Additional information was received on 01-dec-2022.The physician had no ecg signal to monitor the patient¿s heart rhythm.The signal loss was only on the ecg.The signal loss was observed on both the carto® and recording system.There were no catheters in the body.Additional information was received on 04-dec-2022.They were not sure if anesthesia had body surface signals.What they meant by ¿the physician didn¿t have ecg¿ was that there was what looked like a disconnected lead from the patient causing the ecg to look very irregular on the recording system.Additional information was received on 06-dec-2022.The ecg noise issue was also noted on carto signals.The physician not having an ecg signal to monitor the patient¿s heart rhythm provided on 01-dec-2022, was assessed as mdr reportable for bad/no ecg all channels (body surface and intracardiac).The awareness date for this reportable signal issue was 01-dec-2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 08-dec-2022.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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a bad/no ecg all channels (body surface and intracardiac) issue occurred.The device evaluation was completed on 25-jan-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, magnetic sensor functionality test and electrical 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 or current leakage issues were observed.Per the event, an electrical test was performed and no electrical issues were found.The magnetic and electrical 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.A manufacturing record evaluation was performed, and no internal actions related to the complaint was found during the review.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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16065521
• MDR Text Key: 308492097
• Report Number: 2029046-2022-03250
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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: 30912321L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2022
• 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: CBL, 34 HYP/34 LEMO, 10'.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.; UNKNOWN BRAND RECORDING SYSTEM.; UNK_CARTO 3.