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

Model Number D134805

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was signal interference on all ecg signals and the physician did not have intact ecg signal available to monitor the patient.It was reported there was extreme noise on all the ecg leads when the thermocool® smart touch® sf bi-directional navigation catheter was plugged in.They checked all the connections and it persisted.They unplugged the abator and it resolved.When they plugged it back in, it came back.They changed the ablation cable, and it did not resolve.They changed the thermocool® smart touch® sf bi-directional navigation catheter and it resolved and didn¿t return.Surgery was delayed due to the reported event for 5 minutes.Action taken to resolve the issue included checking the connections, unplugged/plugged in ablation catheter, changed the ablation cable, changed ablation catheter and then the procedure was successfully completed.There were no patient consequences.During the signal interference, the affected catheter was inside the patient¿s body.The signal interference (noise/loss) was observed in both carto and recording system.They didn¿t think the physician have any intact ecg signal available to monitor patient heart rhythm.

Manufacturer Narrative

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 ref.# (b)(4).

Manufacturer Narrative

On 16-jan-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was signal interference on all ecg signals and the physician did not have intact ecg signal available to monitor the patient.It was reported there was extreme noise on all the ecg leads when the thermocool® smart touch® sf bi-directional navigation catheter was plugged in.They checked all the connections and it persisted.They unplugged the ablator and it resolved.When they plugged it back in, it came back.They changed the ablation cable, and it did not resolve.They changed the thermocool® smart touch® sf bi-directional navigation catheter and it resolved and didn¿t return.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.The electrical 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.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.A manufacturing record evaluation was performed for the finished device number lot and no internal action 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 ref.# (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: 16058031
• MDR Text Key: 308475293
• Report Number: 2029046-2022-03243
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/15/2023

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: 30851060L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/16/2023; 01/24/2023
• Supplement Dates FDA Received: 01/19/2023; 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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: THMCL SMTCH SF BID, TC, D-F.; UNSPECIFIED CATHETER CABLE.