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 10/09/2018

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 a patient underwent a procedure with a carto 3 system and a map shift issue occurred.A map shift of roughly 2 centimeters was reported with the use of the carto 3 system during a procedure.Additional event information received on (b)(6) 2018, indicates that no cardioversion or patient movement occurred prior to the map shift.No error message relating to a map shift was noted on the carto 3 system.The shift occurred prior to fast anatomical mapping and noted by the position of the catheters.There was no patient consequence.

Manufacturer Narrative

It was reported a patient underwent a procedure with a carto 3 system and a map shift issue occurred.Product evaluation details: a carto 3 system check was proposed by the technical service respresentative, but the service was declined by the customer.No other medical procedures have been done utilizing the carto 3 system since reporting the issue.The biosense webster field service engineer reported that three reminders were sent to the customer with no feedback.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 ref # (b)(4).

Manufacturer Narrative

On 11/6/2018, the manufactured date was received.Therefore, device manufacture date has been populated with 2/24/2014.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: 8042886
• MDR Text Key: 128249954
• Report Number: 2029046-2018-02246
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• 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: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1