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

Catalog Number D134805

Device Problems Erratic or Intermittent Display (1182); Communication or Transmission Problem (2896)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

Hold for rw 2.8 it was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was noise was an all on intracardiac (ic) and body surface (bs) signals.It was reported the catheter had a lot of movement artifacts on the carto 3 system.Caller stated the catheter was "jumping and wiggling" on the screen.Caller stated there was also artifact on the body surface signals on the carto 3 system during ablation.Caller stated some of the ecg leads also had noise on both the carto 3 system and the recording system.The ablation cable was replaced with no resolution.Caller checked the grounding pad and replaced the ground electrode on the 12 lead with no resolution.When the catheter was replaced, the issue resolved.There was no patient consequence.The customer¿s reported noise and jumping icon on the screen were not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 10-jan-2024, additional information was received indicating the noise was an all on intracardiac (ic), body surface (bs) signals and the physician did not have any other monitor available to monitor patient heart rhythm while the catheter was in the patient¿s body.As such, the event was reviewed and reassessed as an mdr reportable malfunction since the lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

Manufacturer Narrative

On 30-jan-2024, 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.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

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was noise was an all on intracardiac (ic) and body surface (bs) signals.It was reported the catheter had a lot of movement artifacts on the carto 3 system.Caller stated the catheter was "jumping and wiggling" on the screen.Caller stated there was also artifact on the body surface signals on the carto 3 system during ablation.Caller stated some of the ecg leads also had noise on both the carto 3 system and the recording system.The ablation cable was replaced with no resolution.Caller checked the grounding pad and replaced the ground electrode on the 12 lead with no resolution.When the catheter was replaced, the issue resolved.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, magnetic sensor functionality and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device was connected to the carto 3 system and it was visualized and recognized correctly.No jumping icon or other magnetic issue were observed during the test.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 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 recommendations stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.In relation to the electrical issue, 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.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.# pc-(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: 18617520
• MDR Text Key: 334882414
• Report Number: 2029046-2024-00362
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31185704L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2023
• 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