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 09/24/2018

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.Still pending is the manufactured date.A supplemental report will be submitted to update manufactured date field.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a carto 3 system and a ¿map shift¿ issue occurred.There were no patient consequences.At the beginning of the post-ablation remap, a map shift of at least 3 mm was observed.There were no errors.There were no patient movements or cardioversions prior to the map shift.A new map was created and the procedure continued.This event was originally considered non-reportable, however, bwi became aware of additional information indicating there was no patient movement and no cardioversions on 10/2/2018 and have reassessed the event as reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a carto 3 system and a ¿map shift¿ issue occurred.There were no patient consequences.At the beginning of the post-ablation remap, a map shift of at least 3 mm was observed.There were no errors.There were no patient movements or cardioversions prior to the map shift.A new map was created and the procedure continued.This event was originally considered nonreportable, however, bwi became aware of additional information indicating there was no patient movement and no cardioversions on 10/2/2018 and have reassessed the event as reportable.Device evaluation details: a biosense webster inc.(bwi) field service engineer (fse) confirmed that the issue could not be duplicated.The fse advised the bwi representative to use default template.Two cases were completed successfully thereafter.The system is in service and ready for use.The complaint history of the system was reviewed, and no more similar problems were found since the issue occurred.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 10/20/2018, the manufactured date has been provided.Therefore, device manufacture date has been populated to 2/27/2013.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: 7987761
• MDR Text Key: 124837831
• Report Number: 2029046-2018-02191
• 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,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1