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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) utilizing a carto® 3 system and a map shift issue occurred.During a premature ventricular contraction (pvc) ablation procedure, carto v7 glitches were seen throughout case.Advanced reference annotation (ara) did not work from the start of the case, it would only pick up pvc intermittently.Electrocardiogram was replaced and made clean; however, ara still only worked intermittently on pvc.Throughout case could only intermittently use home, end, and delete buttons.Two maps were grouped.Fast anatomical mapping (fam) was edited for one map and lost 50% of fam from both maps and a huge geometry shift of about 10 cm was seen.The system did not display any error/warning message.No cardioversion or patient movement occurred prior to the map shift.A new map had to be created which was compared with the old map and was in a completely different location.The procedure was continued and subsequently completed without further issues.No patient consequences were reported.This event was originally considered non-reportable, however, bwi became aware of a additional information on 10/19/2020 and reassessed as mdr reportable.

Manufacturer Narrative

It was reported a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) utilizing a carto® 3 system and a map shift issue occurred.It was also reported that throughout case could only intermittently use home, end, , and delete buttons.Device evaluation details: it was confirmed that the customer declined service for the unit as the complaint was reported for documentation purpose only.The carto® 3 system manufacturer requested the study data for investigation, however, the biosense webster inc.Representative only provided partial data since the full data was not available; it had been deleted from the carto® 3 system.As such, investigation of the reported map shift and the ara issues was not possible.The history of customer complaints reported for the carto® 3 system was reviewed and no more similar map shift problems were found since the issue occurred.The carto® 3 system is ready for use.It was also reported that the home, end, <, >, and delete buttons worked intermittently.However, it was confirmed that the service was declined by the customer.The complaint was reported for documentation purpose only.Investigation of the reported issue was not possible.The history of customer complaints reported during the last year associated with carto® 3 system # 34425 was reviewed and no similar complaints were found for the issue of related to intermittent availability of the buttons.A manufacturing record evaluation was performed for the carto® 3 system # 34425, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 10848609
• MDR Text Key: 227972782
• Report Number: 2029046-2020-01741
• 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: 09/16/2020

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 Model Number: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 07/05/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1