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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Insufficient Cooling (1130); Electrical Shorting (2926)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.All ecg signals were lost during the case.About midway, there was noise on all the ecg signals.The noise was displayed on the recording system the carto 3 system, the life pack, and the anesthesia monitoring system.Then a current leakage error (number unknown) was displayed on the carto 3 system.They exchanged the cable and then a temperature control error was flashing between 60 & 90 degrees celsius on the smartablate remote.They exchanged the catheter, and the issue was resolved.The case continued without any further incident.The carto 3 system and the smartablate remote are working per specs.The temperature cut-off value error did not occur during ablation.The system did not continue to ablate above temperature cut off value.The generator parameters were set at power- 35w.It is unknown why the current leakage error occurred.The signal interference (noise/loss) was observed on bs channels.The signal interference (noise/loss) was observed on all monitoring devices.No ecg/ekg signal was available for the physician to monitor the patient¿s heart rhythm carto, cardiolab, lifepak, mckesson, and anesthesia monitoring all showed noise.During the signal interference/loss, the affected catheter was inside the patient¿s body.Current leakage is not mdr-reportable.High temperature is not mdr-reportable.The noise issue (bad/no ecg on all channels) is mdr-reportable.

Manufacturer Narrative

On 30-nov-2021, bwi received additional information regarding the event.The observed signal interference (noise) was observed on the following products: carto, recording system, lifepak, anesthesia 5 lead, cath lab 5 lead.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 4-jan-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.All ecg signals were lost during the case.About midway, there was noise on all the ecg signals.The noise was displayed on the recording system the carto 3 system, the life pack, and the anesthesia monitoring system.Then a current leakage error (number unknown) was displayed on the carto 3 system.They exchanged the cable and then a temperature control error was flashing between 60 & 90 degrees celsius on the smartablate remote.They exchanged the catheter, and the issue was resolved.The case continued without any further incident.The carto 3 system and the smartablate remote are working per specs.Device evaluation details: visual analysis of the returned sample revealed no damages on the smart touch bidirectional sf device.An electrical test was performed in accordance with bwi procedures.The device passed the electrical values within specification.The instructions for use contain the following warning stated: - to minimize electrocardiogram noise, the following guidelines should be followed.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 the carto 3 system manual: immediately disconnect body surface ecg cable and all device extension cables from the piu.Press acknowledge in the caution window to enable ablation through the patient interface unit (piu).If the error persists, shut down the piu and contact biosense webster service and support department.- if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If the temperature is still not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.The event described could not be confirmed as the device performed without any electrical issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.A manufacturing record evaluation was performed for the finished device 30638330l number, and no internal actions related to the complaint were found during the review.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12932281
• MDR Text Key: 287259008
• Report Number: 2029046-2021-02118
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2022

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 Expiration Date: 09/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 11/30/2021; 01/04/2022
• Supplement Dates FDA Received: 12/26/2021; 01/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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.; SMARTABLATE GENERATOR.