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 06/13/2018

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a mapshift occurred.It was reported that there was a map shift on the carto 3 when making a new map of the chamber.No error messages were displayed, there was no patient movement.The patches were also in place.No active troubleshooting could be performed, the case completed successfully.Additional information received confirm that no error messages were displayed when the issue occurred.The shift was noted when starting a new map.The patient was in the same rhythm as the previous map.It also confirms that cardioversion didn¿t occur prior to the map shift.A biosense webster inc.(bwi) field service engineer spoke to the bwi field representative and confirmed the mapshift occurred near the end of the case.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system and a mapshift occurred.It was reported that there was a map shift on the carto 3 when making a new map of the chamber.No error messages were displayed, there was no patient movement.Product evaluation details the bwi field service engineer spoke with the bwi field representative and advised the occurred issue could be caused by the patient relaxing under sedation.No service requested by the account.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.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: 7679357
• MDR Text Key: 114033805
• Report Number: 2029046-2018-01784
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1