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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Patient Device Interaction Problem (4001)

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

Event Date 11/30/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an ventricular tachycardia (vt) ablation procedure with a carto® 3 system.A vt carto case was delayed due to issues with the system.An issue with the patient interface unit (piu) has been reported.There was a sound before the piu crashed and had a lot of distortion; error 6401"ultrasound magnetic distortion "; it then crashed and got error 1"no connection to the piu¿.They then shut it down and restarted it.The error 6401"ultrasound magnetic distortion " kept happening randomly during the case but they finished the case with it.It's been said they used sensor catheter during the case.It's been mentioned they had a major map shift just in one direction, they then had to start the procedure from scratch.The professor had to redo a procedure at risk because of that.Case was completed, no patient consequences, however there was a 1-hour delay.Version used was v7.1.80.33.Follow up has been conducted to request additional information regarding map shift.Communication issue regarding piu is not mdr-reportable.Communication issue regarding ultrasound is not mdr-reportable.Map shift is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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 investigational analysis has been completed on 26-feb-2023.It was reported that an unknown patient underwent an ventricular tachycardia (vt) ablation procedure with a carto® 3 system.A vt carto case was delayed due to issues with the system.An issue with the patient interface unit (piu) has been reported.There was a sound before the piu crashed and had a lot of distortion; error 6401"ultrasound magnetic distortion "; it then crashed and got error 1"no connection to the piu¿.They then shut it down and restarted it.The error 6401"ultrasound magnetic distortion " kept happening randomly during the case but they finished the case with it.It's been said they used sensor catheter during the case.It's been mentioned they had a major map shift just in one direction, they then had to start the procedure from scratch.The professor had to redo a procedure at risk because of that.Case was completed, no patient consequences, however there was a 1-hour delay.Version used was v7.1.80.33.Investigational analysis: an investigation was initiated by the device manufacturer to investigate the issue.It was found that alert 402: "map: magnetic distortion." was displayed on the carto 3 system.According to the carto 3 system instructions for use: "a distortion in the magnetic field has been detected near the catheter connected to the map socket.The location data received from this catheter may be inaccurate." mapping was continued despite multiple appearance of the error.The issue is related to user error.The history of customer complaints reported during the last year associated with carto 3 system # 11975 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the system 11975, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 07-feb-2023, it was noted that the h6.Medical device problem code of computer operating system problem (a1104) was inadvertently omitted on the 3500a initial report #mwr-06122022-0001311002.Therefore, the h6.Medical device problem code has been populated.

• 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: 16020694
• MDR Text Key: 305874070
• Report Number: 2029046-2022-03215
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• 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: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2011
• 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
• Patient Outcome(s): Life Threatening