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

Model Number FG540000

Device Problems Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

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

Event Date 11/01/2022

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 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 ischemic vt ablation procedure with a carto® 3 system and the surgery was prolonged due a system issue.It was reported that they got the error 1 and 2, it sometimes takes them 20 min before moving to error 3.Sometimes they get stuck on error 2, therefore, they need to restart and try again.They check the fiber optic cable and try to switch it to the second port but it doesn¿t always fix the issue.Same goes for powering on and off, it doesn't always fix the issue.The case completed after there was a 1-hour delay.There were no patient consequences.The delay didn¿t cause any complication to the patient, just a very long wait before to start the procedure.No other intervention was required.

Manufacturer Narrative

It was reported that a patient underwent an ischemic vt ablation procedure with a carto® 3 system and the surgery was prolonged due a system issue.It was reported that they got the error 1 and 2, it sometimes takes them 20 min before moving to error 3.Sometimes they get stuck on error 2, therefore, they need to restart and try again.They check the fiber optic cable and try to switch it to the second port but it doesn't always fix the issue.Same goes for powering on and off, it doesn't always fix the issue.The case completed after there was a 1-hour delay.There were no patient consequences.The delay didn't cause any complication to the patient, just a very long wait before to start the procedure.No other intervention was required.Device evaluation details: a field service engineer (fse) visited the account and confirmed the issue.Fse replaced the defective main module card with a new one.Required tests were performed after main module card replacement per acceptance testing procedure (atp).All tests passed.In additional, the fiber optic duplex cable was replaced with a new one since the current was in bad condition.Issue resolved.The system is ready for use.In additional, replaced main module card was sent to the manufacture for investigation.The customer complaint was confirmed.During investigation the main module card was found defective and caused reported issue.The main module card was repaired, and the issue was resolved.It was reported that the fiber optic duplex cable is not available anymore.Therefore, the manufacturer investigation cannot be performed.The history of customer complaints reported during the last year and associated with carto 3 system # 13164 was reviewed.Two (2) similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system with serial # 13164, 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 ref.#(b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: the date of manufacture was inadvertently omitted from the 3500a supplemental (follow-up) mdr #1.The field has now been populated with the manufacture date.

• 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: 16018386
• MDR Text Key: 305872645
• Report Number: 2029046-2022-03204
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/01/2023

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: 11/23/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 08/01/2023; 08/01/2023
• Supplement Dates FDA Received: 08/01/2023; 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2012
• 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
• Patient Outcome(s): Other