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

Model Number FG540000

Device Problems Computer Operating System Problem (2898); Patient Device Interaction Problem (4001)

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

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system and the system froze multiple times causing a 40-minute delay in the surgical procedure.It was reported that an issue with the workstation was encountered.When it was turned on, it froze.It was restarted twice but it was still frozen.After 20 minutes, the carto® 3 system restarted by itself but when the study was started, the following error message was displayed three times: "the carto application must restart".A decision was made to use an old workstation instead of the current one.A spare device was used to finish the procedure after a 40-minute delay.The physician stated that there was no patient consequence.

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.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 hardware investigation was completed on 18-jan-2022.It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system and the system froze multiple times causing a 40-minute delay in the surgical procedure.It was reported that an issue with the workstation was encountered.When it was turned on, it froze.It was restarted twice but it was still frozen.After 20 minutes, the carto® 3 system restarted by itself but when the study was started, the following error message was displayed three times: "the carto application must restart".A decision was made to use an old workstation instead of the current one.A spare device was used to finish the procedure after a 40-minute delay.The physician stated that there was no patient consequence.Device evaluation details: it was confirmed that the issue was resolved with a spare workstation and the replacement workstation was delivered to the customer.The workstation that was having an issue was sent to the device manufacturer for investigation and repair.The customer complaint was confirmed.During the investigation, it was found that the issue was caused by a defective 4tb hard disk.The hard disk was replaced, and the issue was resolved.The history of customer complaints reported during the last year associated with carto 3 system # 10170 was reviewed.No similar complaints were found.A manufacturing record evaluation (mre) was performed for the system # 10170, and no internal actions related to the reported complaint condition were identified.Based on the mre, h4.Device manufacture date was updated.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on 23-jan-2022, it was noted that follow up report #1 (mwr-18012022-0001115000), on the ¿h6.Type of investigation¿ field, was missing the code of ¿testing of actual/suspected device (b01)¿.Therefore, this field was updated.In addition, the field ¿h3.Device evaluated by manufacturer?¿ was updated to a ¿yes¿ since the device was returned to the device manufacturer for investigation and repair.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12871992
• MDR Text Key: 285042082
• Report Number: 2029046-2021-02054
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/28/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/18/2022; 01/23/2022
• Supplement Dates FDA Received: 01/18/2022; 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2009
• 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: UNK_CARTO 3.
• Patient Outcome(s): Other