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

Catalog Number FG540000

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a carto® 3 system where a map shift occurred.It was reported that about halfway thru the case everything seemed to have shifted up about 3 cm.There was no patient movement.The patches were checked and seemed to be fine.It was also reported that all signals were in completely different locations.No errors were displayed.They remapped and noted everything was in a completely different spot.No patient consequence was reported.The ecg signal issue is not reportable, however, the map shift issue for which the carto did not display any immediate error or warning message, such map shift is a reportable malfunction.

Manufacturer Narrative

It was reported that about halfway thru the case everything seemed to have shifted up about 3 cm.There was no patient movement.The patches were checked and seemed to be fine.It was also reported that all signals were in completely different locations.No errors were displayed.They remapped and noted everything was in a completely different spot.No patient consequence was reported.Product evaluation: the biosense webster inc.(bwi) field service engineer (fse) spoke with a bwi representative and was informed that repair has been declined.The issue was called in for documentation purposes only and system is ready for use.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.Manufacturer's ref # (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: 7446414
• MDR Text Key: 106150619
• Report Number: 2029046-2018-01455
• 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: 03/22/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1