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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 03/17/2023

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 ref.# (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 that while performing ablation in the right vein of the left atrium, a map shift occurred on the carto 3 system.The caller noted that the patient didn't move or cough.The caller stated that they noticed a significant change in the map displayed on the carto 3 system and that the map had moved forward.The caller stated that they remapped and noticed that there was something wrong.The caller stated that when the ablation catheter was inserted into the body, the new map did not seem to align with the fast anatomical mapping (fam) map.The physician disconnected the ablation catheter and reconnected the ablation catheter to the patient interface unit (piu) and the issue was resolved.The procedure continued.It was also reported that after they were completed with the left atrium and when they went to the right atrium to perform ablation, they noticed a flicker in the screen in the map displayed on the carto 3 system.The caller stated that a map shift occurred again.The caller noted that there was no movement of the patient.The caller stated that they replaced the ablation catheter with a pentaray catheter to map and the map seemed more inaccurate after mapping with the pentaray catheter.They remapped the right atrium and continued the procedure.The caller stated that there was no significant movement between the old lesions and the new lesions.The caller stated that the physician completed the procedure as quickly as possible.The caller noted that there were no errors displayed on the carto 3 system.The caller stated that there was nothing out of the norm displayed on the carto 3 system.Visually on the screen, the approximate difference in catheter location before and after map shift was a few mm.There was no cardioversion or patient movement prior to the map shifts.

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 that while performing ablation in the right vein of the left atrium, a map shift occurred on the carto 3 system.The caller noted that the patient didn't move or cough.The caller stated that they noticed a significant change in the map displayed on the carto 3 system and that the map had moved forward.The caller stated that they remapped and noticed that there was something wrong.The caller stated that when the ablation catheter was inserted into the body, the new map did not seem to align with the fast anatomical mapping (fam) map.The physician disconnected the ablation catheter and reconnected the ablation catheter to the patient interface unit (piu) and the issue was resolved.The procedure continued.Device evaluation details: the bwi field service engineer (fse) arrived on site for troubleshooting and system check.Fse ran relative and cloud test and cube test to see if there was a map misalignment issue.Both tests passed.Fse stayed for case support to ensure there were no further issues.Fse confirmed that the issue was not duplicated during multiple cases.System is ready for next use.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.An investigation was initiated by the manufacturer to look into the issue.Data related to the reported issue was requested from the account.Per the user answer, the data related to the issue is no longer available as it was deleted from the work station.No investigation can be performed as the data related to the issue was not provided.No additional information for investigation was found.The history of customer complaints reported during the last year and associated with carto 3 system # 12096 was reviewed.No similar additional complaint was found.A manufacturing record evaluation was performed for the carto 3 system # 12096, and no internal action related to the reported complaint condition were identified.Based on the completed mre, the h4.Device manufacture date has been populated with 29-dec-2011.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16742420
• MDR Text Key: 313721107
• Report Number: 2029046-2023-00816
• 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: 06/02/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• 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
• Treatment: UNKNOWN ABLATION CATHETER; UNK_PENTARAY