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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the biosense webster inc.(bwi) representative that there was a map shift on the carto® 3 system.There were no alerts, errors, nor messages for the map shift, and it was only noticed when they were advancing the catheter and the catheter was showing outside of the shell.The map shift was discovered when moving the catheter to a different vein.It was seen during ablation.The bwi representative stated that there was no patient movement.A remap was performed and the procedure was completed successfully.No adverse patient consequence was reported.It was also stated that post remap, there was a prompt that there was a ¿patient moment¿ and that the system needed to reinitialize.The bwi representative looked at the location set up and patch #5 showed as stripped.The acl magnetic current wire was reseated, and the issue was resolved.The location patch issue was assessed as not mdr reportable.This is highly detectable.Most likely harm is a procedure delay or cancellation.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the biosense webster inc.(bwi) representative that there was a map shift on the carto® 3 system.There were no alerts, errors, nor messages for the map shift, and it was only noticed when they were advancing the catheter and the catheter was showing outside of the shell.The map shift was discovered when moving the catheter to a different vein.It was seen during ablation.The bwi representative stated that there was no patient movement.A remap was performed and the procedure was completed successfully.No adverse patient consequence was reported.It was also stated that post remap, there was a prompt that there was a ¿patient moment¿ and that the system needed to reinitialize.The bwi representative looked at the location set up and patch #5 showed as stripped.The acl magnetic current wire was reseated, and the issue was resolved.The location patch issue was assessed as not mdr reportable.This is highly detectable.Most likely harm is a procedure delay or cancellation.An investigation was initiated by the device manufacturer.After reviewing the received data, it was found that the reported map shift was caused due to mapping with high metal threshold that were indicated on the screen by an error message.Issue is related to user error.The history of customer complaints reported during the last year associated with carto 3 system #11206 was reviewed.No similar additional complaints were found.A manufacturing record evaluation (mre) was performed for the system 11206, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17371732
• MDR Text Key: 319586662
• Report Number: 2029046-2023-01559
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1