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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Patient Device Interaction Problem (4001)

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

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system.There was a 30-minute delay in a vt case.It was reported that after plugging the ablation catheter, they didn't have ecg (electrocardiogram) signal on the ep recording system (eprs).The signal was fine on carto signal.They tried to change the ecg out cable to eprs, disconnected and reconnected all catheter in the front of the patient interface unit (piu) but it didn't solve the issue.They plugged the ecg cable directly to the eprs and they had signal which means the cable isn't the problem.They used only the carto signal to continue the case.Procedure was completed, no patient consequences, 30-minute delay reported.It was not reported that intervention was required due to the delay.Version v.7.2.0.663 was used.Signal loss of external system (while carto signal is still available) is not mdr-reportable.However, this event is being reported for the 30-minute surgical delay.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

On 24-jan-2023, the product investigation was completed.Device evaluation details: it was reported that after plugging the ablation catheter, they didn't have ecg (electrocardiogram) signal on the eprs (electrophysiology recording system).The signal was fine on carto signal.It was confirmed that all connection and ic (intracardiac) out board was checked, loop back test was performed and all the signals between eprs and carto signals are ok.The issue was not duplicated since then.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

On (b)(6) 2023, the product investigation was updated with the manufacture record evaluation.The h6 type of investigation codes were updated to reflect that.A manufacturing record evaluation was performed for the finished device 11896 number, and no internal action related to the complaint was found during the review.The manufacture date was updated to (b)(6) 2011.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: 16053734
• MDR Text Key: 306216075
• Report Number: 2029046-2022-03241
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2023

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: 12/07/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/24/2023; 06/19/2023
• Supplement Dates FDA Received: 02/16/2023; 07/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2011
• 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): Other