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 01/21/2020

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system and a map shift occurred with no error message, no change in posture or position and no cardioversion.It was reported that there was map shift error and the ablation catheter appeared to be outside of the heart but the fluoroscopy appeared to be in the same place.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.Additional information was received on january 23, 2020.There was no error message.The issue was seen during mapping.The shift appeared to be a centimeter plus off.No cardioversion was performed.There was no report of patient consequence.Although the issue was stated that it resolved by replacing the catheter, since the caller implied a map shift, the map shift issue is assessed to be investigated under the carto® 3 system.This map shift issue described was assessed as not reportable.Additional information was received on march 12, 2020 stating there was also no change in posture or position of the patient.The map shift issue with no error message, no change in posture or position and no cardioversion has been assessed as a reportable malfunction.This awareness date for this reportable malfunction is march 12, 2020 as this is the date of when we received the additional information that there was also no posture or position changes.

Manufacturer Narrative

On 7/5/2020, the product investigation was completed.It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system and a map shift occurred with no error message, no change in posture or position and no cardioversion.It was reported that there was map shift error and the ablation catheter appeared to be outside of the heart but the fluoroscopy appeared to be in the same place.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.Additional information was received on january 23, 2020.There was no error message.The issue was seen during mapping.The shift appeared to be a centimeter plus off.No cardioversion was performed.There was no report of patient consequence.Device investigation details: the issue was investigated under ir #86605.The study data was requested by htc to investigate the issue.Cas reported that the data isn't available because it was deleted from the system.Investigation of the map shift issue was not possible.The cas also confirmed that the issue was not duplicated since then and no service was required.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #29094 was reviewed.No similar complaints were found there out of 8 additional complaints.A manufacturing record evaluation was performed for the system 29094, 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: 9875228
• MDR Text Key: 200483628
• Report Number: 2029046-2020-00469
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 07/05/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1