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 07/28/2020

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift occurred with no error message and no patient movement and no cardioversion.During the procedure yesterday, while mapping, a map shift was observed on the carto® 3 system.This occurred midway through the procedure after completion of cryo ablation on the left veins and they moved to the right veins which there was an obvious and significant shift of roughly 20 mm from pre fast anatomical mapping (fam) and post fam was observed.There were no error codes or learn new messages being displayed.The patches were checked and were found to be in the same position.The map shift was noticed within advanced catheter location (acl) tolerance within matrix.There was no cardioversion nor patient movement prior to the map shift.A new map was created to complete the procedure.No patient consequences were reported.The reported map shift with no error message and no patient movement and no cardioversion was assessed as a mdr reportable malfunction.

Manufacturer Narrative

The device evaluation was completed on 10/28/2020: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.During the procedure yesterday, while mapping, a map shift was observed on the carto® 3 system.This occurred midway through the procedure after completion of cryo ablation on the left veins and they moved to the right veins which there was an obvious and significant shift of roughly 20 mm from pre fast anatomical mapping (fam) and post fam was observed.There were no error codes or learn new messages being displayed.The patches were checked and were found to be in the same position.The map shift was noticed within advanced catheter location (acl) tolerance within matrix.There was no cardioversion nor patient movement prior to the map shift.A new map was created to complete the procedure.No patient consequences were reported.The biosense webster, inc.Field service representative spoke to the biosense webster, inc.Representative and was advised that they initialized the system prior to the fluoroscopy system being in the field.This led to increased metal interference causing a map shift.User error in the hardware setup caused the issue.System is operational.Data related to the reported issue was sent to the device manufacturer for investigation.The issue was investigated at by the device manufacturer.The issue was not reproduced in the device manufacturer sqa lab.No additional investigation can be performed as the data related to the issue arrived without recordings.A manufacturing record evaluation was performed for the carto 3 system #12500, 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 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: 10453951
• MDR Text Key: 204736042
• Report Number: 2029046-2020-01110
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CRYO ABLATION CATHETER; UNKNOWN BRAND PATCHES