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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that the work station automatically restarted in the middle of the procedure.After the work station rebooted, the physician stated that there was a lateral map shift compared to the fluoro system.The procedure continued using the fluoro system instead of the carto 3 system.Fse to evaluate the issue.Dispatch was approved by css rh.

Manufacturer Narrative

Correction required as it was noticed that the b5.Event description in the initial 3500a medwatch report was incorrect.The correct event description has now been populated into b5.Removed from b5: "it was reported that the work station automatically restarted in the middle of the procedure.After the work station rebooted, the physician stated that there was a lateral map shift compared to the fluoro system.The procedure continued using the fluoro system instead of the carto 3 system.Fse to evaluate the issue.Dispatch was approved by css rh" added to b5: "it was reported that a patient underwent an right atrial flutter (r-afl) with a carto 3 system and a map shift issue occurred.It was reported that the work station automatically restarted in the middle of the procedure.After the work station rebooted, the physician stated that there was a lateral map shift compared to the fluoro system.The procedure continued using the fluoro system instead of the carto 3 system.There were no patient consequences.On (b)(6) 2020, additional information was received indicating the map shift was later reported to be questionable.The physician who is very experienced stated that ¿he thinks that there may have a map shift¿.The issue occurred upon finishing up the case, so the physician chose to continue without remapping.It was not possible to determine the approximate difference in the map from pre to post map shift.The physician did not perform a cardio version prior to the map shift.The spontaneous reboot occurred while mapping.The reported spontaneous reboot issue has been assessed as not mdr reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.The map shift has been assessed as an mdr reportable malfunction.This event was originally considered nonreportable, however, bwi became aware of additional information on (b)(6) 2020 reassessed the map shift issue as mdr reportable." device evaluation details: the device evaluation has been completed.The study data of the case was reviewed.It was found that the changing position of fluoro caused high metal on the one of the green patch sensors and catheter, and as a result the map shift.It was found that the alert 412 : patch 1: magnetic distortion, was shown by the carto 3 system despite the initial report indicating there were no alerts from the system.According to instructions for use (ifu), metal interference is caused by a ferromagnetic material placed within the magnetic working area might affect location findings.Major interference triggers an error or alert message.The issue has been related to ¿man caused¿ since the system alerted the user about the high metal values due to changing of fluoro position.The biosense webster inc.Field service engineer (fse) has confirmed that account did not require system testing.The account has kept using the carto 3 system.The system is functional.A manufacturing record evaluation was performed for the system # 29177, 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 ref # (b)(4).

Event Description

It was reported that a patient underwent an right atrial flutter (r-afl) with a carto 3 system and a map shift issue occurred.It was reported that the work station automatically restarted in the middle of the procedure.After the work station rebooted, the physician stated that there was a lateral map shift compared to the fluoro system.The procedure continued using the fluoro system instead of the carto 3 system.There were no patient consequences.On (b)(6) 2020, additional information was received indicating the map shift was later reported to be questionable.The physician who is very experienced stated that ¿he thinks that there may have a map shift¿.The issue occurred upon finishing up the case, so the physician chose to continue without remapping.It was not possible to determine the approximate difference in the map from pre to post map shift.The physician did not perform a cardio version prior to the map shift.The spontaneous reboot occurred while mapping.The reported spontaneous reboot issue has been assessed as not mdr reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.The map shift has been assessed as an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of additional information on (b)(6) 2020 reassessed the map shift issue as mdr reportable.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine 92618
• MDR Report Key: 9669387
• MDR Text Key: 200446836
• Report Number: 2029046-2020-00186
• 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: 01/17/2020

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: 01/27/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/29/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1