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 12/06/2019

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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.During the ablation procedure, there was a 2 cm map shift.The system did not indicate any errors.The map shift was discovered during mapping by moving the catheter around and the catheter location did not line up with the fast anatomical mapping (fam) map we had previously made.It was no longer possible to advance the a pentaray into the right sided pulmonary veins of left atrial fam map.No cardioversion and no patient movement was noticed.There was no report of patient consequence.The observed map shift has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and a map shift issue occurred.During the ablation procedure, there was a 2 cm map shift.The investigational analysis completed 2/4/2020.The field service engineer (fse) discussed the issue with the johnson and johnson representative.It was confirmed that the issue was caused by metal interference from equipment located nearby.Fse advised johnson and johnson representative on the lab environment setup, to prevent the issue.The issue was not duplicated during the following 3 cases.Fse confirmed that the system is operational.Mre was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.The issue is related to an internal investigation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (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: 9533604
• MDR Text Key: 200059645
• Report Number: 2029046-2019-04078
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1