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

Model Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift with no error message, no patient movement and no cardioversion issue occurred.Initially it was reported that a map shift occurred while exchanging the ablation catheter for the octaray catheter in order to perform a post-map after the ablation was completed.It was noted that the patient did not move, the patches did not move, and the fluoroscopy did not move.They created another map and started over completely for the post-map.They pulled the catheters from the patient after the map was completed.Additional information was received on (b)(6) 2023.The system did not provide any error message.They did a post map and the catheter was showing tpi in the middle of the fast anatomical mapping (fam) of the pre-mapped vein.They moved the catheter and it was the same for the roof.They made a completely new map and compared the two side by side and the maps did not align at all.The new map was significantly lower than the original.The shift occurred after ablating and going in to post map.The approximate difference in catheter location before and after the map shift was maybe a centimeter.It was hard to say.Provided a photo.The green was pre shift and purple was post.No cardioversion was performed and no patient movement.This event was originally considered non-reportable, however, bwi became aware of additional information that stated that the system did not provide any error message and have reassessed the event as mdr reportable for a map shift with no error message, no patient movement and no cardioversion.The reportable awareness date is (b)(6) 2023.

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).

Manufacturer Narrative

The investigation was completed on 24-may-2023.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system.It was reported that a map shift occurred while exchanging the ablation catheter for the octaray catheter in order to perform a post-map after the ablation was completed.It was noted that the patient did not move, the patches did not move, and the fluoroscopy did not move.They created another map and started over completely for the post-map.They pulled the catheters from the patient after the map was completed.The biosense webster, inc.Field service representative performed a preventative maintenance for the carto 3 system.All tests were completed with pass results.The system is fully functional and is ready for clinical use.The biosense webster, inc.Field service representative uploaded log files for evaluation.The issue was investigated at the device manufacturer.It was found that the map shift was a result of a change in respiration modulation caused a real heart location change with no alert.After the 1st fast anatomical mapping period, the user changed the respiration cycle to be more rapid with less volume, this mode continued until the end of the case.The 2nd fast anatomical mapping phase was performed with such conditions.In practice, as the breathing cycle was changed in order to reduce breathing effect during ablation, the tidal volume became smaller, and the average location of the membrane changed towards lower carto y coordinates.The results are that the new acquired location was shifted due to a real heart move within the body.System is operational.The history of customer complaints reported during the last year associated with carto 3 system # (b)(6) was reviewed.No similar additional complaint was found.A manufacturing record evaluation was performed for the carto 3 system # (b)(6), 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 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: 16727861
• MDR Text Key: 313663388
• Report Number: 2029046-2023-00799
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• 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: OCTARAY CATHETER.; UNKNOWN BRAND ABLATION CATHETER.