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 Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 11/19/2019

Event Type  Death  

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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04022 and 2029046-2019-04016 are related to this same incident.Manufacture ref no: (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a carto 3 system and a thermocool smart touch sf bi-directional navigation (stsf) catheter and suffered ventricular tachycardia and death.There was an erasable programmable read only memory (eeprom) error displayed on the carto 3 system.Catheter replacement resolved the issue.In the middle of the case, char was noticed on the tip of the catheter.The catheter was cleaned, reinserted in the body, and the procedure continued.Later in the case, the catheter was pulled out of the body, and more char was noticed on the tip of the catheter.While mapping with the ablation catheter, data streaming errors (278, 268 & 258) displayed on the carto 3 system.The patient interface unit (piu) was shut down and rebooted.Troubleshooting was performed and the location pad was disconnected and reconnected.However, errors continued to display.The study was exited and reopened with no resolution.The patient interface unit (piu) and the workstation were then completely shut down.Thereafter, the workstation was booted up.A new study with a default template was opened then the piu was powered.The issue resolved.After resolving the data streaming errors, the case was canceled, as the patient was not stable enough to continue the treatment of arrhythmia.Electrocardiogram (ecg) signals and right ventricular pace was not able to be seen while the carto 3 system was down.However, the physician did have at least one ecg signal available to monitor patient¿s heart rhythm.There were no issues related to temperature or flow of the catheter.Generator was set to power control mode with a cutoff of 45 watts.The patient received and unknown anticoagulant during the procedure.The activated clotting time was 250-300 seconds, which was maintained for the bulk of the procedure.No ablations were over 60 seconds or 40 grams.Default pre-ablation high setting was used.Heparinized saline was used as irrigation fluid with default irrigation settings.Visitag parameters were set to: respiration, 2.5mm stability, 25% 5g force over time, 2mm tag size, and tag index color option.This was a 3rd repeat ischemic ventricular tachycardia (vt) ablation for that patient.Only stsf was used for mapping due to physician¿s concern of inducing vt with pentaray.About 1.5 hour into mapping in the ventricle wall, the catheters disappeared, and all the signals disappeared on the carto and the recording system.The biosense webster inc.(bwi) representative spent 23 minutes with the technical services on the phone, and eventually was advised to open a new study.The new study resolved the issue.The physician indicated 2 hours of the procedure was lost.During the troubleshooting, the patient developed vt several times and defibrillation was performed 3 times.After the 3rd shock the vitals started to drop, the heart started getting weaker and weaker and even though there were qrs complexes were visible.The blood pressure was very low (26/10-s), resulting in chest compressions being initiated.The physician decided to perform several more ablations and the case was stopped.The ablation procedure was stopped before reaching the physician¿s desired endpoint due to severe hypotension.Physician indicated the exact cause of this hypotension is unknown.Physician opinion is that the prolonged anesthesia led to drop in blood pressure.The catheter was used with default irrigation settings.Same issue happened to the same patient on (b)(6) for a previous vt ablation with carto on the same system with the same piu, with a different bwi representative.They never saw these errors except for these two cases.Per the physician, extended hospital stay was required.The patient was hospitalized but may not be due to the procedure but due to the patient¿s underlying condition.Patient passed away during hospitalization as a result of ventricular tachycardia.

Manufacturer Narrative

The product investigation was reopen to process corrections for coding, clarify investigation details and update the investigation conclusion.It was noticed that h6.Result code 110 (design error) was reported in a previous medwatch in error.The code was selected by mistake.There are no design errors identified with the carto 3 system.Please consider the h6.Result code 110 (design error) to be removed.It was clarified that the data streaming error was resolved by rebooting the system, reloading the application, and using a default template during the case.Later, the field service engineer (fse) tested the system: all tests passed.The system is operational.Fse replaced main module with another one as a preventive action.The suspicious main module was tested by a bwi subcontractor and determined the reported data streaming error was not reproduced.The main module was tested and found fully functional.However, the data streaming error is a known issue which listed in carto 3 system instructions for use.The hospital acted to clear the errors exactly as it¿s indicated in the instructions for use (ifu) and with technical services support.It was also clarified that in order to verify the reported ecg signal loss, the local biosense webster inc.(bwi) representative was contacted to request the study data for further investigation.However, the bwi representative reported that the workstation was re-imaged as a preventive action per fse request.The required data was erased as part of the re-imaging, and therefore it was not available for further evaluation.In addition, it was also reported the patient was hospitalized post procedure due to continued ventricular tachycardia (vt) episodes and the physician subsequently reported the patient expired.Based on the information available the outcome of death is considered a cascade of harms from the prolongation of procedure resulting in the patient¿s deteriorating arrhythmia.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

On 8/27/2020, it was noticed that the device manufacture date was inadvertently omitted from previously reported mdrs.As such, the field has now been populated with the device manufacture date of 3/18/2010.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

It was reported that a 71-year-old male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a carto 3 system and a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and suffered ventricular tachycardia and death.There was an erasable programmable read only memory (eeprom) error displayed on the carto 3 system.While mapping with the ablation catheter, data streaming errors (278, 268 & 258) displayed on the carto 3 system.In the middle of the case, char was noticed on the tip of the catheter.The investigational analysis completed 4/27/2020.The data streaming error issue was resolved by rebooting the system, reloading the application, and using a default template during the case.Later, the field service engineer (fse) tested the system.All tests passed.The system is operational.Fse replaced main module (sn: (b)(6)) with another one as a preventative action.The suspected main module was tested by sanmina; a biosense webster inc.(bwi) subcontractor (rma# (b)(4)).The reported data streaming errors issue was not reproduced.The main module was tested and found fully functional.However, it is a known issue which is listed in carto 3 system instructions for use (ifu).The hospital acted to clear the errors exactly as it is indicated in the ifu.The echocardiogram (ecg) signal loss, which is occurred at the same time with data streaming error was not confirmed.Manufacturer engineer confirmed that the carto is designed to transfer ecg signals to electrophysiology recording system always, even it¿s impacted by data streaming related issue.In additional, local cas was contacted and asked for sending the study data for further investigation.The cas reported that the ws was re-imaged as a preventive action per fse request.The required data was erased as part of the re-imaging, and therefore it was not available.No more similar issues were observed in the hospital since then.No more actions were requested by the hospital regarding the problem.The hospital keeps using the system.Catheter replacement resolved the erasable programmable read only memory (eeprom) issue.Reported char issue is not related to the carto system.A manufacturing record evaluation was performed for the system and no internal actions were identified.An internal corrective action has been opened to investigate the data streaming error issue.Section h8 has been updated from initial use of device to reuse.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.

Manufacturer Narrative

During an internal review on may 28, 2020, a correction was noted to the 3500a initial report.In ¿h10.Addnl.Manf.Narrative/corrctve data¿ as it originally referenced an incorrect manufacturer reference number.Originally it stated, ¿biosense webster manufacturer's reference number: (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04016 are related to this same incident.¿ it should have stated, ¿biosense webster manufacturer's reference number: (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04016 are related to this same incident." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture ref no: (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: 9492766
• MDR Text Key: 171955229
• Report Number: 2029046-2019-04022
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Death; Hospitalization; Required Intervention