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

Catalog Number FG560000

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

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

Event Date 10/03/2023

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.As we started the case, there was no error.We started ablating the left veins and while on the ridge physician complained that there is a map shift.I checked my patched by pressing ctrl+ p and they looked all okay, but when i brought up the metal values, the values were high for patch 5 and patch 6 (front patch).We started remapping and after some time, multiple errors popped up like spu synchronization error, illegal pacing channel selection and finally the piu communication error.I restarted the piu and ngen and everything started working fine.When we started ablating the right veins the map shift didn't look that serious as left side.The issue occurred during ablation and it was around 3cm.There were no errors provided by the system, only physician thought that the catheter movement was not aligning with the fast anatomical mapping (fam).No cardioversion was performed, neither did the patient moved as the whole procedure was performed under general anesthesia.There was a 15 minute delay in the procedure but it was completed successfully.

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.As we started the case, there was no error.We started ablating the left veins and while on the ridge physician complained that there is a map shift.The issue occurred during ablation and it was around 3cm.There were no errors provided by the system, only physician thought that the catheter movement was not aligning with the fast anatomical mapping (fam).No cardioversion was performed, neither did the patient moved as the whole procedure was performed under general anesthesia.Device evaluation details: 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 values that were indicated on the screen by an error messages.Issue is related to user error.In addition, multiple errors popped up like spu synchronization error, illegal pacing channel selection and finally the patient interface unit (piu) communication error.It was confirmed that the errors were not duplicated after rebooting the piu and the ngen rf generator.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #r10032 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system #r10032, 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18013049
• MDR Text Key: 326631267
• Report Number: 2029046-2023-02439
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG560000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN NGEN