MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and a map shift issue occurred.During the procedure, we did three maps.Between map 1 and map 3, the system show an important shift map without warning.There was no delay in the procedure and no adverse patient consequences were reported.The observed map shift issue has been assessed as an mdr reportable malfunction.The event date is unknown.As such, the 1st day of the alert month has been entered as the event date ((b)(6) 2020).

Manufacturer Narrative

On 7/7/2020, the product investigation was completed.It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and a map shift issue occurred.During the procedure, we did three maps.Between map 1 and map 3, the system show an important shift map without warning.There was no delay in the procedure and no adverse patient consequences were reported.Device evaluation details: data related to the reported issue was sent to the htc.The issue was investigated at htc (investigation request#: (b)(4)).It was confirmed that the reported map shift was caused by the patient movement during mapping despite it was reported that there was no patient movement prior to the map shift.A patient move impacted the chest patch but not the back patch.As a result, the catheter locations were also shifted with no warning (and not compensated).Patch location shows that the chest patches moved between 10 to 15 mm with respect to their original positions.The back patches didn't move.According to carto 3 instructions for use, "in rare cases, 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 is cardioverted).Due to such internal anatomic displacements, there might be misalignment of the map to the heart location", "the system will not give a warning and an incorrect map (map shift) might be generated"."when in doubt, close the current map and begin a new one".There was no system malfunction.The issue was related to user error.System is operational.The history of customer complaints reported during the last year associated with carto 3 system # 11133 was reviewed.No similar complaints were found there out of 4 additional complaints.A manufacturing record evaluation was performed for the carto 3 system # 11133, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10136429
• MDR Text Key: 195578810
• Report Number: 2029046-2020-00678
• 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
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, F, 2-6-2