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 02/14/2019

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 ablation procedure for atrial fibrillation (afib) with a carto 3 system, and during mapping a silent map shift issue occurred twice.The initial map shift occurred post cardio-version while evaluating the patch positions.A new map was created as the shift was significant.The initial observed map shift has been assessed as not reportable as this is a normal expected response from the system.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The second map shift occurred mid-way into a re-map as it was noticed that the locations were off.Map shift was observed during catheter manipulation as it appeared outside of the already created map.The approximate difference in catheter location before and after map shift was approximately 1-2 cm.No system errors or alerts were observed.No adverse patient consequences were reported.The second observed map shift issue has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a carto 3 system, and during mapping, a silent map shift issue occurred twice.The investigational analysis completed 3/12/2019.The biosense webster inc.(bwi) field service engineer (fse) advised that the map shift issue be reported for documentation purposes.However, no service was requested.System is functional and ready for use.The map shift had not returned in later case.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 has cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.Device history record 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.On 3/14/2019 additional information was provided indicating the device manufacture date of: 3/1/2017.Manufacturer ref 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: 8410419
• MDR Text Key: 139167873
• Report Number: 2029046-2019-02787
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1