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 08/01/2019

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.Manufacturer's ref.No: (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 with no error message and no patient movement or cardioversion occurred.It was reported that there was a map shift on the carto® 3 system.There was no patient movement or cardioversion performed.There were no errors indicating a map shift occurred and no prompts to reinitialize the catheter visualization.The shift seemed to self-correct.Additional information was received stating that the physician could not get back to original ablation line.This is when they noticed that the coronary sinus catheter was much higher than the original screen shot taken at the beginning of the procedure.The difference in the catheter location before and after the map shift was not known.This map shift with no error message and no patient movement or cardioversion was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system.There was a map shift on the carto® 3 system.There was no patient movement or cardioversion performed.There were no errors indicating a map shift occurred and no prompts to reinitialize the catheter visualization.The shift seemed to self-correct.Additional information was received stating that the physician could not get back to original ablation line.This is when they noticed that the coronary sinus catheter was much higher than the original screen shot taken at the beginning of the procedure.The difference in the catheter location before and after the map shift was not known.The biosense webster inc.Field service engineer followed up the issue with the biosense webster inc.Representative.It was reported that the map shift issue resolved by itself and has not duplicated.Reported issue was investigated by the device manufacturer.Conclusion: there is nothing that looks like a map shift.In the absence of image captures or any other indications on the map shift, there was one place where the catheter metal jumps significantly and the catheter seems to be out of fast anatomical mapping ¿fam¿.As soon as the metal was returned to normal values, the catheter was back in place.Reported issue is not duplicated.System is operational.The manufacturing record evaluation was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate the ¿map shift¿ issue.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: 8919024
• MDR Text Key: 155185710
• Report Number: 2029046-2019-03562
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CORONARY SINUS CATHETER