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 02/28/2019

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.Still pending is the manufactured date.Therefore, a supplemental 3500a report will be submitted to update the manufactured date.  (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system and it was described that a fast anatomical mapping (fam) map shift occurred during the procedure.The map shifted anteriorly, and the carto® 3 system user moved the map little by little to line up with catheter location until it was 2 cm off from the original location.A new fast anatomical mapping (fam) map was eventually created.There were no error messages and no metal introduced into the field.The case was completed successfully and there was no patient consequence.This issue was originally assessed as not reportable.Additional clarification was requested to this complaint.However, no further information had been made available.Map shift without exclusion of patient movement or cardioversion is not reportable.Therefore, with the information available, this event was assessed as not reportable.Additional information was received on (b)(6) 2019, and it was reported that there was no cardioversion or patient movement.The map shift was seen during ablation and discovered with contact force readings and distance from the fam shell.The approximate difference in catheter location before and after the map shift was approximately one centimeter.Per the additional information received stating that the map shift was with no error message and patient movement or cardioversion, this map shift has been reassessed to a reportable issue.The awareness date for this report is (b)(6) 2019.

Manufacturer Narrative

The manufactured date was provided on march 25, 2019.Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system and it was described that a fast anatomical mapping (fam) map shift occurred during the procedure.The map shifted anteriorly, and the carto® 3 system user moved the map little by little to line up with catheter location until it was 2 cm off from the original location.A new fast anatomical mapping (fam) map was eventually created.There were no error messages and no metal introduced into the field.The case was completed successfully and there was no patient consequence.Additional information was received on march 4, 2019, and it was reported that there was no cardioversion or patient movement.The map shift was seen during ablation and discovered with contact force readings and distance from the fam shell.The approximate difference in catheter location before and after the map shift was approximately one centimeter.The biosense webster, inc.Field service engineer (fse) followed up on the issue with the biosense webster, in.Representative.The field service engineer confirmed with the biosense webster, inc.Representative that the issue could not be duplicated at following cases and no test required.The system is operational.Device history record (dhr) 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.Manufacturer's reference # (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: 8444880
• MDR Text Key: 140179913
• Report Number: 2029046-2019-02859
• 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: 02/28/2019

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 Catalogue Number: FG540000
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1