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 10/25/2018

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.Manufacturers ref # (b)(4).

Event Description

It was reported a patient underwent a procedure with a carto 3 system and a map shift issue occurred.It was reported that during ablation, catheters disappeared on the carto 3 system, then the catheters then appeared stripped, disappeared, and there was a map shift.No active troubleshooting could be performed, the case completed successfully.No patient consequences reported.

Manufacturer Narrative

Correction: the following information was inadvertently omitted from the initial 3500a: ¿it was reported that they had plugged the balis needle into the carto 3 system¿s 20b pin block so that it could be visualized on the carto 3 system while rf energy was applied as needle was crossing the septum.The caller then reported that the catheters disappeared on the carto 3 system.The catheters then appeared stripped, disappeared, and there was a map shift.The issues occurred during ablation.The caller reported that it seemed that the carto 3 system received energy from the needle.The smartablate generator (g4c-3434) displayed "0" and shut off on its own twice.No active troubleshooting could be performed, the case completed successfully.Issue also reported for documentation.The caller advised the physician that this appeared to be off label use on the carto 3 system.Further troubleshooting and guidance with the connections were made through the process as provided by the representative from balis.The visualization issues are not mdr reportable since the potential that it could cause or contribute to a serious injury or death is remote.¿ additional information: on (b)(6)2018, additional information was received indicating there was no entitlement/service contact in place for this unit and the account did not want to pay for the unit to be evaluated.A biosense webster inc.(bwi) field service engineer (fse) expressed they wanted to assess the unit in order to understand what damage could or did happen to the unit when used in the manner described in the initial reported event.Product investigation details: the fse followed up with bwi representative and advised that the carto 3 system is not designed to have rf energy delivered through port 20 pole b.According to information provided in the initial event description the physician was informed that this appeared to be off label use of the carto 3 system.Due to the possible off label use, the technical service department requested the fse evaluate the system.Fse performed the functional tests per acceptance testing procedure (atp) and all tests passed.The fse reported that the map shift issue was not duplicated during next cases when abiding to the correct system use.No other issues were reported.System is ready for use.The 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).

• 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: 8081770
• MDR Text Key: 128437445
• Report Number: 2029046-2018-02301
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1