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

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

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 wherein a mapshift issue occurred.The customer described the event as, the map geometry shifted and then eventually went back to normal.No adverse patient consequences were reported.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a carto 3 system wherein a mapshift issue occurred.The customer described the event as, the map geometry shifted and then eventually went back to normal.No adverse patient consequences were reported.Product evaluation details: a biosense webster field service engineer (fse) visited on site and performed cube and acl testing.System passed tests and could not duplicate issue.The fse provided case support and system functioned normally.Issue was not duplicated.System 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: 7391298
• MDR Text Key: 104538032
• Report Number: 2029046-2018-01399
• 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: 03/08/2018

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: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1