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

Model Number FG540000

Device Problems Electrical /Electronic Property Problem (1198); Patient Device Interaction Problem (4001)

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

Event Date 08/24/2022

Event Type  Injury  

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 4.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 a ventricular tachycardia (vt) ablation procedure with carto® 3 system and the case had to be cancelled due to error and after a two (2) hour delay.It was reported that they had screening error and patch errors (on the green and yellow patches) saying that the patches were detached.The error was switching to different patches on both, green and yellow patches.They changed the patches, but it didn¿t help.They turned off the patient interface unit (piu), restarted it and did a lot of troubleshooting on the piu ports but nothing helped.The troubleshooting lasted 2 hours and was very complicated.They had to cancel the case.There was no patient consequences.Additional information received indicated the clinical person in charge reported they were not aware of ¿any case of death due to cancelation of the procedure¿.The patient was sedated via propofol.No patient consequences due to delay.No transseptal puncture was performed.The event is reportable for the procedure delay and procedure cancellation.

Manufacturer Narrative

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with carto® 3 system and the case had to be cancelled due to error and after a two (2) hour delay.It was reported that they had screening error and patch errors (on the green and yellow patches) saying that the patches were detached.The error was switching to different patches on both, green and yellow patches.They changed the patches, but it didn¿t help.They turned off the patient interface unit (piu), restarted it and did a lot of troubleshooting on the piu ports but nothing helped.The troubleshooting lasted 2 hours and was very complicated.They had to cancel the case.There was no patient consequences.Device evaluation details: the device evaluation has been completed.It was confirmed that the issue was resolved by replacing the faulty patch unit with another one that was delivered to the customer.The issue was resolved.The replaced patch unit was sent to the device manufacturer for investigation and repair.The customer complaint ¿screening error and patches error (on the green and yellow patches) saying that the patches were detached¿.The testing was performed and the issue was not confirmed.All the tests ended without falling.No failure found.The issue was not duplicated since the time it occurred.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system # 35310 was reviewed.There are no additional complaints is similar to reported issue.A manufacturing record evaluation was performed for the system #35310, 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).

Manufacturer Narrative

The manufactured date has been provided.Therefore, field h4.Device manufacture date have been populated.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15473997
• MDR Text Key: 300559911
• Report Number: 2029046-2022-02293
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2019
• 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): Hospitalization