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

Model Number FG540000

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

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.Reports 2029046-2020-00357 and 2029046-2020-00358 are related to this same incident.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.At the beginning of an atrial fibrillation (afib) ablation procedure, the fast anatomical map (fam) matched with the contours taken by the soundstar® eco diagnostic ultrasound catheter.After the ablation started, the map shifted, and the left atrium looked more inferior.A combination of erasing and famming was used to get the anatomy close, but it never was the same.No error message was displayed on the system, the map shift was discovered when attempting to put the pentagram in the left veins after ablated the right veins.The approximate difference in catheter location before and after mapping is unknown.However, it was reported the difference was extensive.No cardioversion or patient movement occurred prior to the map shift.No patient consequences were reported.The observed map shift has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.It was reported that at the beginning of an atrial fibrillation (afib) ablation procedure, the fam match with the contours taken by the soundstar catheter.After the ablation started, the map shifted, and the left atrium looked more inferior.A combination of erasing and fast anatomical mapping was used to get the anatomy close, but it never was the same.No error message was displayed on the system.The map shift was discovered when attempting to put the pentagram in the left veins after ablated the right veins.The approximate difference in catheter location before and after mapping is unknown.However, it was reported the difference was extensive.No cardioversion or patient movement occurred prior to the map shift.No patient consequences were reported this was reported in error.Therefore all further updates will be reported under report 2029046-2020-00358.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2020-00357 and 2029046-2020-00358 are related to this same incident.Manufacture reference no: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9795568
• MDR Text Key: 200802711
• Report Number: 2029046-2020-00357
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• 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
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SOUNDSTAR ECO GE 10F CATHETER