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

Model Number FG540000

Device Problems Computer Software Problem (1112); Patient Device Interaction Problem (4001)

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

Event Date 04/13/2021

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.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 atrial tachycardia (at) ablation procedure with a carto® 3 system wherein a piu issue occurred, and the remainder of the procedure was cancelled.It was reported that during the procedure, an error 24 ¿carto location pad issue¿ appeared on the carto® 3 system.Also, a red light was observed at the back of the piu.Unspecified troubleshooting was required but the issue remained despite troubleshooting.The physician decided to abort the procedure as no other system was available at the facility to rebook the case.The patient was cardioverted to prevent heart failure symptoms while waiting for the case to be rebooked.The error appeared before any anesthesia was given to the patient.Prolonged hospitalization was not required.Per carto ifu, the error 24 is related to failure in piu mag tx card bit.This piu issue alone is not considered not mdr reportable since the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 6/2/2021, additional information was received which indicated the physician considers the case cancellation to be an increased risk for the patient as the patient had a cardioversion to temporarily improve his heart failure symptoms.It is likely the patient experienced an exacerbation of disease due to case cancellation; the continuation of disease due to failure to terminate atrial tachycardia (at) due to case cancellation.The heart failure symptoms was a pre-existing congenital patient condition.Based on the additional information received on june 2, 2021, this event has been reassessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a carto® 3 system wherein a piu issue occurred, and the remainder of the procedure was cancelled.It was reported that during the procedure, an error 24 ¿carto location pad issue¿ appeared on the carto® 3 system.Also, a red light was observed at the back of the piu.Unspecified troubleshooting was required but the issue remained despite troubleshooting.The physician decided to abort the procedure as no other system was available at the facility to rebook the case.The patient was cardioverted to prevent heart failure symptoms while waiting for the case to be rebooked.On 6/2/2021, additional information was received which indicated the physician considers the case cancellation to be an increased risk for the patient as the patient had a cardioversion to temporarily improve his heart failure symptoms.It is likely the patient experienced an exacerbation of disease due to case cancellation; the continuation of disease due to failure to terminate atrial tachycardia (at) due to case cancellation.The heart failure symptoms was a pre-existing congenital patient condition.Based on the additional information received on june 2, 2021 this event has been assessed as mdr reportable.Device evaluation details: the investigational analysis has been completed.A field service engineer (fse) visited the account.The location pad(lp)/mag tx card kit was found defective and replaced with a new one.The system passed required tests after replacement and found operational.The replaced lp/mag tx card kit was sent to the device manufacturer for investigation.The customer complaint was confirmed, the mag tx card was found defective and caused error 24.The card was repaired.Location pad was then found operational.The history of customer complaints reported during the last year associated with carto 3 system, serial # 11201 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the system # 11201, 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).

• 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
• MDR Report Key: 12059659
• MDR Text Key: 266896290
• Report Number: 2029046-2021-00988
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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
• Date Manufacturer Received: 07/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other