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 12/12/2017

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 products: unspecified pentaray catheter (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a carto 3 system where a map shift occurred in conjunction with a visualization issue.During the case, the fast anatomical map was noted to be ¿off,¿ and the splines of a pentaray catheter that was being used could no longer be visualized.The customer did not troubleshoot the issue, but still completed the case successfully.No patient consequences were reported.Multiple attempts have been made to obtain additional information regarding this event, but none has been made available.The potential that the catheter visualization issue could cause or contribute to an adverse event is remote.However, a map shift that occurs without an error message and is not caused by patient movement or cardioversion can be a result of a system malfunction, presenting a potential risk to the patient.As a result, this event is being conservatively reported to fda in the absence of clarifying information.

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrial fibrillation with a carto 3 system where a map shift occurred in conjunction with a visualization issue.Product investigation summary: a biosense webster inc.(bwi) field service engineer (fse) contacted the account's bwi representative to troubleshoot the issue, however, the fse was informed the case data was backed up and then removed from the carto 3 workstation.As such, the necessary data for investigation of the issue could not be pulled for review.Therefore, the complaint was not confirmed.The account's bwi representative did report that no other map misalignments have reoccurred since then.The system is fully functional.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: 7184777
• MDR Text Key: 97069780
• Report Number: 2029046-2018-01078
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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: 12/12/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1