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

Catalog Number FG540000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

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.Concomitant product: thermocool smarttouch sf catheter, product code: d134805, lot #: 17685763l.Lasso catheter.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system.It was reported that a current leakage error was displayed when the thermocool smarttouch sf catheter was connected.The catheter was replaced and the issue resolved.A map shift issue was also reported.No error message displayed.No trouble shooting could be performed.The procedure was completed successfully.The additional information received stated that after mapping with the lasso catheter, the thermocool smarttouch sf catheter did not match the fast anatomical map created.It was also confirmed that no error populated on the carto 3 system and that the patient did not move nor was cardioverted prior to the map shift.The current leakage issue was assessed as not reportable as this issue was highly detectable and requires adjusting system components to continue with the procedure.Patient safety was unaffected by this issue.The map shift issue was assessed as a reportable malfunction.Such map shifts with no error message, could potentially be caused by system malfunction and there was a potential risk to the patient.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system.It was reported that a current leakage error was displayed when the thermocool smarttouch sf catheter was connected.The catheter was replaced and the issue resolved.A map shift issue was also reported.No error message displayed.No trouble shooting could be performed.The procedure was completed successfully.The additional information received stated that after mapping with the lasso catheter, the thermocool smarttouch sf catheter did not match the fast anatomical map created.It was also confirmed that no error populated on the carto 3 system and that the patient did not move nor was cardioverted prior to the map shift.The biosense webster field service engineer (fse) confirmed that the reported current leakage error was resolved after replacement of the catheter.System is operational.The fse confirmed that the reported issue was reproduced during the next case and during additional troubleshooting.It was realized that these were not necessarily map shift issues but catheter visualization issues caused by error 402.The catheter was not visualizing correctly on the screen due to this error.Error 402 is a magnetic distortion on map.Because of this error, the map catheters were showing up off of the map.Once catheters from a different lot were used, error 402 was resolved and catheter was showing up correctly on the map.It was confirmed that the issue was caused by a defective lot of catheters.System evaluation was requested.Annual service visit was completed by the fse.All tests passed and system is ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.(b)(4).

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 6843751
• MDR Text Key: 85608289
• Report Number: 3008203003-2017-01001
• Device Sequence Number: 1
• Product Code: DQK
• 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: 08/08/2017

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 Catalogue Number: FG540000
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 03/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1