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 06/05/2020

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # (b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred.It was reported that a map shift occurred after ablating the left pulmonary vein.The issue resolved on its own after about an hour.A default template was used.No error was displayed on carto.The shift was noticed since the fast anatomical mapping (fam) wasn¿t matching with the ablator forces and the location of the veins had moved.The approximate difference in catheter location before and after map shift was of 5-10 mm.The shift was confirmed with new sound contours from intracardiac echo (ice).No patch movement was recognized on carto.No cardioversion prior to shift.It was also reported that the carto 3 system displayed a magnetic sensor error 116 when the pentaray catheter was plugged into the patient interface unit (piu).The catheter cable was replaced, and the issue remained.The catheter was replaced, and the issue resolved.

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.It was found that the reported map shift was caused due to high metal values during fast anatomical mapping (fam) acquisition and determined to be related to an internal action.The issue is expected to be handled per software defect management procedure.A manufacturing record evaluation was performed for the system (b)(6), 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 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: 10206513
• MDR Text Key: 200043805
• Report Number: 2029046-2020-00783
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, F, 2-6-2; SPLIT HANDLE EXT. CABLE, 9' LG