MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problem Signal Artifact/Noise (1036)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been 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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and carto® 3 system and there was signal interference on all ecg (intracardiac and body surface) on the carto® 3 system, recording system and anesthesia monitor.Initially, it was reported that during ablation, spike signals would appear on all the signals intermittently.The catheter cable was replaced with no resolution.The pump was turned off with no resolution.The grounding cables were checked, and the pump was grounded with no resolution.The case was completed with the issues and no further troubleshooting was performed.No patient consequence was reported.With the information available, this event was assessed as not mdr reportable since there was no evidence that the patient's heart rhythm was not visible to the operator on all electrograms (body surface and intracardiac) on all systems available.Therefore, the risk to the patient was low.Additional information was requested and a response was received on may 19, 2021.The signal interference (noise) was observed on all ecg (intracardiac and body surface), on the carto® 3 system and recording system.The staff said that the noise was on the anesthesia monitor as well, but the reporter did not get a chance to confirm.The catheter was inside the body and we only had this problem during ablation.Sometimes, not even during every ablation.Nor for the entire duration of every ablation.Per the additional information received clarifying that the signal interference (noise) was on all ecg (intracardiac and body) on the carto® 3 system, recording system and anesthesia monitor, this event has been reassessed as mdr reportable under both the ez steer¿ nav bi-directional electrophysiology catheter and carto® 3 system.The awareness date for this reportable issue is may 19, 2021.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and carto® 3 system.It was reported that during ablation, spike signals would appear on all the signals intermittently.The catheter cable was replaced with no resolution.The pump was turned off with no resolution.The grounding cables were checked, and the pump was grounded with no resolution.The case was completed with the issues and no further troubleshooting was performed.No patient consequence was reported.Additional information was received stating the signal interference (noise) was observed on all ecg (intracardiac and body surface), on the carto® 3 system and recording system.The staff said that the noise was on the anesthesia monitor as well, but the reporter did not get a chance to confirm.The catheter was inside the body and we only had this problem during ablation.Sometimes, not even during every ablation.Nor for the entire duration of every ablation.The biosense webster field representative spoke with the biosense webster representative and discussed troubleshooting for noise during ablation.The biosense webster representative informed the biosense webster field representative that upon follow up, the system did not have any issues.System is operational.It was clarified that the reported spike appeared sometimes.Not even during every ablation, nor for the entire duration of every ablation.This issue was investigated at the device manufacturer.It was found that the ecg spike during ablation is a known ablation artifact and not a new phenomenon.It is related to a system limitation.The history of customer complaints associated with the carto 3 system # 13340 reported during the last year was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 13340, and no internal actions related to the reported complaint condition were identified.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: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 11985043
• MDR Text Key: 255711784
• Report Number: 2029046-2021-00912
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4MM NAVIGATIONAL BI-DIRECT; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND PUMP; UNKNOWN BRAND RECORDING SYSTEM; 4MM NAVIGATIONAL BI-DIRECT; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND PUMP; UNKNOWN BRAND RECORDING SYSTEM