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

Model Number FG540000

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system and unwanted pacing device malfunction occurred.It was described that during the procedure, there was an issue with double pacing.When the customer chose a routed channel, the system delivered pacing from that channel and also delivered pacing from ref/deca 7-8 port.Replacing the workstation did not resolve the issue.There was no patient consequence reported.The unwanted pacing issue was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system and unwanted pacing device malfunction occurred.It was described that during the procedure, there was an issue with double pacing.When the customer chose a routed channel, the system delivered pacing from that channel and also delivered pacing from ref/deca 7-8 port.Replacing the workstation did not resolve the issue.There was no patient consequence reported.The field service engineer (fse) confirmed that the issue was resolved by replacing the patient interface unit (piu) location pad (lp) kit that was delivered to the customer and installed.Also, the advanced catheter localization (acl) card was installed in order to comply with the patient interface unit (piu) configuration on site.The workstation was replaced during troubleshooting.All acceptance testing procedure (atp) tests passed successfully.The system was ready for use.The suspected patient interface unit (piu)/location pad was sent to the device manufacturer for investigation.It was found that the issue was caused by faulty ecg card.The opto-switch on the ecg card was found defective.The opto-switch on the ecg card was replaced and the issue resolved.An internal corrective action has been opened.A manufacturing record evaluation was performed for the carto 3 system 11167, and no internal actions related to the reported complaint condition were identified.The unwanted pacing issue is related to an internal corrective action which has been opened to investigate "opto-switch and tvs failures." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Additional information was received on (b)(6)2020 and it was reported that pacing stimulator that was used during the procedure was a boston ls pro.It was also noted that the pacing was planned, and that unwanted pacing was being delivered.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (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: 9492290
• MDR Text Key: 199723727
• Report Number: 2029046-2019-04024
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

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: 11/21/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/26/2020
• Supplement Dates FDA Received: 01/22/2020; 03/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC LS PRO PACING STIMULATOR