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

Model Number FG540000

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent left atrial tachycardia (at- left) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a carto® 3 system and suffered cardiac tamponade requiring pericardiocentesis.During the procedure there was noise on the distal end of the thermocool® smart touch¿ bi-directional navigation catheter.The cables were exchanged twice, and the catheter was exchanged to a thermocool® smart touch® sf bi-directional navigation catheter.The issue persisted.A biosense webster, inc.Representative was called for further troubleshooting.The caller was advised to disconnect the direct connect cable from the patient interface unit (piu) then plug it back in.The pacing channels were turned off and the noise was still persistent.The caller was advised to disconnect the intracardiac (ic) direct cable to the ge and to plug it back in.The noise persisted.The caller is going to call the local field service engineer (fse) for further troubleshooting and call back.The caller called back advising that changing out the catheter cable did not resolve the issue and that changing out the catheter resulted in a catheter sensor error.The catheter was change again (3rd catheter) thermocool® smart touch® sf bi-directional navigation catheter, which then resulted in the noise persisting.Disconnecting the generator cable did not resolve the issue.Changing out the generic intracardiac (ic) out cable did not resolve the issue.The caller stated that there was a red light on the back of the patient interface unit (piu) that was intermittently blinking.The issue was eventually resolved by replacing the ecg card.Later in the procedure the patient developed a pericardial effusion.A pericardiocentesis was performed in which 320 cc of fluid was removed from the pericardial space.The patient was stabilized and transferred to the cardiac care unit (ccu) for observation.There was no information provided on extended hospitalization.The magnetic sensor error was assessed as not reportable.The incidence of magnetic sensor error was easily detected by the user.The catheter was inoperable, since it could not be visualized on the carto 3 system.The user had to replace the catheter.The potential risk that it could cause or contribute to a serious injury or death was remote.

Manufacturer Narrative

On (b)(6)2019, it was noticed that the concomitant product was inadvertently omitted from the 3500a initial mdr submitted to fda on (b)(6)2019.The products have now been added to concomitant medical products.Concomitant med products.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Initially, it was reported that biosense webster manufacturer's reference number (b)(4) had two complaints that were related to the same incident.The carto® 3 system (manufacturer report number: 2029046-2019-03843) was reported for ¿h6.Device codes¿ of ¿1036/signal artifact¿ and the thermocool® smart touch® sf bi-directional navigation catheter (manufacturer report number: 2029046-2019-03844) was reported for ¿h6.Patient codes¿ of ¿2226/cardiac tamponade¿.After an internal review on may 7, 2020, a correction was noted for the carto® 3 system as the signal issue was originally assessed as not mdr reportable since the risk to the patient was low.There was no indication that the physician was left without any ecg sources to monitor the patient as only the distal signals of the ablation catheter were affected.Therefore, a correction to the signal issue is necessary to not reportable under the carto® 3 system (manufacturer report number: 2029046-2019-03843).The patient event of the cardiac tamponade remains reportable only under the thermocool® smart touch® sf bi-directional navigation catheter (manufacturer report number: 2029046-2019-03844).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 9276207
• MDR Text Key: 195375798
• Report Number: 2029046-2019-03843
• 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
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 05/07/2020
• Supplement Dates FDA Received: 11/04/2019; 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMRTTCH,BI,NAV,TC,D-F,C3; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F