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

Model Number FG540000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 07/06/2020

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 reference number: (b)(4).

Event Description

It was reported that a female patient ((b)(6) year old) underwent right ventricular outflow tract (rvot) ablation procedure with carto3 system and suffered cardiac arrest that recovered spontaneously.It was reported that no heart beats have been noticed for few seconds.During procedure the system would not allow pacing from the primary port.The customer re-initiated the study and reconnected to a direct pacing port which resolved the issue.It was also reported that during the case customer could not change the pacing location.The primary pacing port was connected initially and then direct pacing port as primary didn¿t allow pacing from map.They were not trying to pace and ablate at same time.The stimulator model was abbot ep 4.This was planned and emergency pacing.The pacing was delivered from the wrong electrode.The adverse event was discovered during use of biosense webster products.No medical intervention was required.The patient did not require extended hospitalization.Pacing was needed , but didn¿t function as expected, this lead to an extended period of asystole.About 10 secs.Dashboard, vector and visitag were used for force visualization.The visitag module was used with the following parameters for stability 3 secs, 3 mm, color option was ablation index.The physician¿s opinion is that the event was due to biosense webster product malfunction and patient condition who was in heart block.

Manufacturer Narrative

It was reported that a female patient (60 year old) underwent right ventricular outflow tract (rvot) ablation procedure with carto3 system and suffered cardiac arrest that recovered spontaneously.It was reported that no heart beats have been noticed for few seconds.During procedure the system would not allow pacing from the primary port.The customer re-initiated the study and reconnected to a direct pacing port which resolved the issue.It was also reported that during the case customer could not change the pacing location.Device evaluation details: per the complainant¿s request, the biosense webster's field service engineer arrived at the account and tested the system.All acceptance tests passed successfully.Further investigation generated the following details: the biosense webster sales representative was requested to export the study data from the system and send it to device manufacturer.The data was received and analyzed.The biosense webster sales representative was also interviewed over the phone.It was found the following event chronology: 10:26 ¿ the procedure was started - 10:26 ¿ error 8 (an error detected in the stimulation routing hardware of the piu) appeared at the beginning of the study, and it was displaying during next 29 minutes - 10:55 - the study was re-initiated, and the pacing stimulator was re-connected from primary to direct pacing port at the same time.- 10:56 ¿ error 8 disappeared, and the procedure was continued - 12:24 ¿ ablation was performed during next 8 minutes - 12:32:13s ¿ flat lines appeared on bs ecg channels.(adverse event - asystole during ablation) - 12:32:17s ¿ pacing stimulated to map channels through direct port but not routed through carto 3.As there was no pacing capture, the stimulator cables were re-connected and map catheter was moved to another location to improve contact with the tissue - 12:32:22s ¿ signals on bs ecg channels re-appeared.Capture of the pacing stimulus is observed.- 13:20 ¿ the procedure was completed based on the chronology, error 8 was resolved 1 hour and 36 minutes before the adverse event (asystole) occurred.Therefore, there is no relation between the reported error 8 and the adverse event.The asystole occurred during radiofrequency ablation using the mapping catheter.The reported extended period of asystole (9 seconds) included ~4 seconds in which the user have waited for the heart to resume its pace, and ~5 seconds in which the user re-connected the stimulator cables pins and re-positioned another catheter for effective pacing.During the asystole, the user unsuccessfully tried to pace from the other catheter in the right ventricle (which was not in contact with the tissue hence no capture).Since there was not capture the user and reconnected the pins to the direct pacing receptacles, which is following the instruction for use (*).(*) carto® 3 instruction for use indicates: if emergency pacing is required, user must connect the pacing stimulator to the direct pacing receptacles above the corresponding catheter socket on the piu front panel.The root cause of the adverse event has been identified as delay in time needed to re-adjust the catheter position for effective pacing.A manufacturing record evaluation was performed for the carto 3 system #11156 and no internal action 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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10344634
• MDR Text Key: 201879933
• Report Number: 2029046-2020-00968
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• 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
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOT EP 4 PACING STIMULATOR; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; UNK_THERMOCOOL SF NAV
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR