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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

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

Event Date 06/29/2022

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 4.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 ref.#: (b)(4).

Event Description

It was reported that a patient underwent a redo atrial fibrillation (redo afib) ablation procedure with a carto® 3 system and a map shift was encountered.It was reported a carto® 3 system was moved into a new room and had a calibration.They did the first case but had some issues.They had map shift and inaccuracy / false measurements without any notice or warning.They tried to create a new map, but each time it was moving it gave an inaccuracy / false measurements.The procedure was completed after a 30 minute delay, but there was no patient consequences.

Manufacturer Narrative

On 15-aug-2022, biosense webster inc.Received additional information indicating the system did not provide an error.The issue was seen during mapping phase.The approximate difference in catheter location before and after map shift was 2 cm.The physician did not perform cardioversion prior to the map shift and there was no patient movement.Clarification was provided for the previously reported statement of ¿false measurements without any notice or warning,¿ the bwi representative states that the force was zero although the catheter was inside the shell.There was no delay.The reported issue of zero force is not mdr reportable since the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a redo atrial fibrillation (redo afib) ablation procedure with a carto® 3 system and a map shift was encountered.It was reported a carto® 3 system was moved into a new room and had a calibration.They did the first case but had some issues.They had map shift and inaccuracy / false measurements without any notice or warning.They tried to create a new map, but each time it was moving it gave an inaccuracy / false measurements.The procedure was completed after a 30 minute delay, but there was no patient consequences.Device evaluation details: the device evaluation has been completed.The biosense webster inc (bwi) field service engineer (fse) confirmed that that second case went normal, no issues seen.Follow-up with the bwi representative indicate the issue was not reproduced.The system is performing to specifications.The reported issue was to be investigated by the device manufacturer but unable because the data related to the issue was not provided by the account.The issue was not duplicated since the time it occurred.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #12595 was reviewed.There are no additional complaints similar to this reported issue.A manufacturing record evaluation was performed for the system #12595, 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; 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15108715
• MDR Text Key: 303276790
• Report Number: 2029046-2022-01709
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2012
• 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