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

Catalog Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

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.This carto 3 system was manufactured before september 24, 2016, therefore no udi is applicable for this product with serial number (b)(4).Concomitant product: 1.Pentaray catheter us catalog #: unknown lot #: unknown.2.Lasso catheter us catalog #: unknown lot #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for persistent atrial fibrillation with a carto® 3 system.After ablation, during verification of isolation, the lasso catheter did not match up with the previously-mapped pulmonary vein.Physician determined that a map shift occurred.Approximate difference in catheter location before and after the map shift was noticeable and estimated to have been likely under 10 (unspecified).Map shift was noted to be within acl tolerance.No errors, alerts, or changes in metal values displayed on the carto 3 system.There were no patient movements or cardioversions prior to the map shift.Physician continued to use the same map and the procedure was successfully completed.There were no patient consequences.This map shift with no error message with no patient movement/cardioversion prior to the map shift was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ablation procedure for persistent atrial fibrillation with a carto® 3 system.After ablation, during verification of isolation, the lasso catheter did not match up with the previously-mapped pulmonary vein.Physician determined that a map shift occurred.Approximate difference in catheter location before and after the map shift was noticeable and estimated to have been likely under 10 (unspecified).Map shift was noted to be within acl tolerance.No errors, alerts, or changes in metal values displayed on the carto 3 system.There were no patient movements or cardioversions prior to the map shift.Physician continued to use the same map and the procedure was successfully completed.There were no patient consequences.The biosense webster field service engineer spoke to the biosense webster field representative.It was confirmed that the reboot resolved the issue and system behaved as normal for following cases.The device history record review (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 reference number: (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: 7871857
• MDR Text Key: 120101603
• Report Number: 2029046-2018-02055
• 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: 08/21/2018

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
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 10/07/2018
• Supplement Dates FDA Received: 10/17/2018
• Patient Sequence Number: 1