MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a carto® 3 system and a procedure delay (high risk) occurred.It was reported that during ablation procedure using the carto® 3 system when booting up the workstation and the patient interface unit (piu), the carto® 3 system showed error 1006 ¿back patch sensor error¿.General anesthesia got delayed until the issue could be resolved.Replacing the back patch cables didn¿t resolve the issue.Switching back to the initial back patch cable and restarting both the workstation and the piu with any metal removed from the vicinity of the location pad resolved the issue at first, so the patient was put under general anesthesia.However, the error reoccurred when getting access.When restarting both the piu and workstation again, the process of establishing communication between the piu and workstation (error 1 to error 2 to error 3), restarted after reaching error 3.The location pad cable was tied to the location pad to prevent any strain on the pig tail, all cables were removed from the piu and both the piu and the workstation were shut down and rebooted.After the reboot all patches were showing within the accuracy zone of the location setup.However, patch 3 was showing metal values around 70.Switching over to the spare back patch cable resolved the issue and the procedure could be completed successfully after a delay of approximately one hour.The customer¿s reported location patch issues are not mdr reportable since the issue is highly detectable and the most likely harm is a procedure delay or cancellation.The reportable event is the procedural delay which is considered to be high risk to patient.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a carto® 3 system and a procedure delay (high risk) occurred.It was reported that during ablation procedure using the carto® 3 system when booting up the workstation and the patient interface unit (piu), the carto® 3 system showed error 1006 ¿back patch sensor error¿.General anesthesia got delayed until the issue could be resolved.Replacing the back patch cables didn¿t resolve the issue.Switching back to the initial back patch cable and restarting both the workstation and the piu with any metal removed from the vicinity of the location pad resolved the issue at first, so the patient was put under general anesthesia.However, the error reoccurred when getting access.All cables were removed from the piu and both the piu and the workstation were shut down and rebooted.After the reboot all patches were showing within the accuracy zone of the location setup.However, patch 3 was showing metal values around 70.Switching over to the spare back patch cable resolved the issue and the procedure could be completed successfully after a delay of approximately one hour.Device evaluation details: the device evaluation has been completed.A biosense webster inc.(bwi) field service engineer (fse) reported that the bwi representative onsite troubleshot the issue and found that the defective green patch sensor cable caused it.The defective green patch sensor cable was switched out with a spare one to resolve the issue and continue the procedure successfully.It was confirmed that the next case was performed without any issue.It was requested to have the defective green patch sensor cable sent to the device manufacturer for investigation, however, it reported that the cable was no longer on the site.It was discarded by the account.Therefore, the cable was not investigated.A manufacturing record evaluation was performed for the carto® 3 system (serial # (b)(6) ), and no internal actions related to the reported complaint condition were identified.Manufacturer¿s ref # (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9509205
• MDR Text Key: 200055152
• Report Number: 2029046-2019-04056
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1