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 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.This carto 3 system was manufactured before september 24, 2016, therefore no udi is applicable for this product with serial (b)(4).The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.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 ablation procedure with a carto® 3 system, and the auto-id catheter connected to the ref/deca port was unable to be visualized.The catheter was disconnected and reconnected, but no resolution occurred.The cable was replaced without resolution.The catheter was then moved to 20 b port and the issue resolved.It was also noted that the contours drawn on the cartosound screen were outside the map.There was no patient consequence.The inability to visualize the catheter is not reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The contours drawn reflecting outside the map was also assessed as not reportable.Additional clarification was requested on this issue.However, no additional information had been provided.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional clarification on the event was received on june 27, 2018, clarifying that a map shift occurred during the ablation phase, as the contours being drawn were outside of the map.No error displayed on the system.Map shift was discovered when the doctor noted steady and consistent contact with little to no catheter movement on ultrasound yet visitags started appearing 2-3 mm away from previous lesion set.The difference in catheter location before and after the map shift was 2 to 4 mm.The physician did not perform cardioversion prior to the map shift and there was no patient movement.Per the response received stating that the shift occurred without cardioversion or patient movement and there was no error message that populated, this map shift issue has been assessed as a reportable malfunction.The awareness date has been reassessed to june 27, 2018.

Manufacturer Narrative

In the initial report, 6/8/2018 was listed as the report submission due date and 7/27/2018 is the correct report submission due date.Manufacturer ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a carto® 3 system, and the auto-id catheter connected to the ref/deca port was unable to be visualized.Additional clarification on the event was received on june 27, 2018, clarifying that a map shift occurred during the ablation phase, as the contours being drawn were outside of the map.The field service engineer (fse) spoke to the bwi representative.Re-selecting the ultrasound allowed her to draw contours correctly.Between cases she booted down and up the patient interface unit (piu), used a default template for next case, and used a ref/deca electrode as normal.Fse advised deleting template and using default, issue did not return.The fse visited the account and performed preventative maintenance and acceptance tests procedures.All tests passed successfully with no issue found.The system is ready for use.The complaint history of the system was reviewed.No similar problems were found since the issue occurred.The history of customer complaints associated with carto 3 system serial # (b)(4) were reviewed.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.Manufacture reference no: (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: 7729071
• MDR Text Key: 115675464
• Report Number: 2029046-2018-01859
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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: 08/22/2018
• Patient Sequence Number: 1