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).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system.During ablation, the map appeared as expected.They started with the superior/posterior wall and then continued inferiorly to the anterior.A map shift was noticed when the ablation points around the anterior/superior left atrium were not aligned with the visitags.Anterior tags appeared to be approximately 2-3 mm inferior to the original tags.This was also noticed on the right superior portion of the left atrium.There were no errors or alerts.Normal metal values were observed at the beginning of the procedure, but upon noticing the visitag misalignment, the metal value of chest patch #5 was 15 (units unspecified).There were no patient movements or cardioversions prior to the map shift.It was noted that this physician checks the fluoroscopy position during the procedure, to include moving the c-arm and adjusting the height of the image receptor.No troubleshooting was performed during the call.There were no patient consequences reported.This map shift issue with no error message and no patient movement or cardioversion prior to the map shift was assessed as a reportable malfunction.The chest patch issue was assessed as not reportable.The potential risk that a c3 location patch issue could cause or contribute to a death or serious deterioration in the patient¿s state of health was remote.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system.It was reported that during the procedure a map shift was noticed, without errors or alerts, normal metal values, with exception of chest patch # 5 with a value of 13.There was no patient movement or cardioversions reported.The shift was noticed when the ablation points around the anterior/superior left atrium were not lining up with the map.The caller was unable to troubleshoot during the call.The biosense webster representative informed that the map shift was caused by metal interference.Raising the c-arm of the fluoroscopy system resolved the issue.No shifts during subsequent cases.Issue is resolved.System is ready for use.The device history record (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: 7884068
• MDR Text Key: 120738459
• Report Number: 2029046-2018-02067
• 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: 09/18/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 10/18/2018
• Patient Sequence Number: 1