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 10/30/2018

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.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an atrial flutter (afl) procedure with a carto 3 system and a map shift issue occurred.It was noted that after fast anatomical mapping (fam) of the right atrium and after ablation had been performed, the cs catheter appeared much lower that were it was mapped.The his also appeared to be located in the middle of the tricuspid valve instead of where it was mapped.The issue was identified post ablation when going back to review the timeline to obtain a post his image and the his was in the middle of the tricuspid valve.The timeline showed the map shift occurred right after adenosine was administered.No cardioversion was performed and no patient movement was noted.No error messages were given by the carto 3 system.No patient consequences were reported.The event of map shift has been assessed as mdr reportable.

Manufacturer Narrative

It was reported a patient underwent an atrial flutter (afl) procedure with a carto 3 system and a map shift issue occurred.No cardioversion was performed, and no patient movement was noted.No error messages were given by the carto 3 system.No patient consequences were reported.Device evaluation details: the device evaluation has been completed.The bwi representative informed the bwi field service engineer (fse) that the shift seemed to be caused by the patient being given adenosine.According to carto 3 instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.As in this case the patient being given adenosine which could cause such kind of movement.The user used a work around and a new map was created; the case completed successfully.System is ready for use.The map shift had not reoccurred in later cases, no service requested.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 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: 8108036
• MDR Text Key: 129325004
• Report Number: 2029046-2018-02366
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1