MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

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.(b)(6).Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: (1) mfr # 2029046-2019-03710 for product code d134805 (cardiac tamponade against the thmcl smtch sf bid, tc, d-f).(2) mfr # 2029046-2019-03711 for product code fg540000j (map shift against the carto 3 system).

Event Description

It was reported that a patient underwent ventricular tachycardia (vt) ablation procedure using two (2) pentaray nav high-density mapping eco catheter, one (1) thermocool® smart touch® sf bi-directional navigation catheter and a carto 3 system and suffered a cardiac tamponade requiring pericardiocentesis and a product malfunction of a map shift with the carto 3 system.During mapping in the right atrium with pentaray nav high-density mapping eco catheter #1, the visualization of the spine became unstable.The visualization matrix had the spines going on and off even within the normal range.So, the cable was changed and the catheter was reconnected but the issue continued.When metal value was checked, value of the catheter which was connected to the 20a port was displayed over 1000.Then, the catheter was changed to pentaray nav high-density mapping eco catheter #2 and the issue improved but the phenomenon of intermittent disappearance of the pentaray nav high-density mapping eco catheter¿s spine continued.After that, it was confirmed that the acquired geometry and visitag were shifted diagonally and downward.It was also reported that during ventricular tachycardia (vt) ablation in the left ventricle, a perforation was noticed after a significant decrease in blood pressure and confirmation of pericardial effusion by echocardiography.The ablation procedure was urgently cancelled.There was no sign of perforation at the time of exchanging the pentaray nav high-density mapping eco catheters.The perforation sign was noticed when the map shifted.Drainage was performed using open heart surgery to remove unspecified amount of fluid.The patient¿s condition was later reported as stable.The physician¿s opinion about the causality of the event is that the map shift may have contributed to the event.The customer¿s reported visualization issues are not considered mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.However, this complaint is reportable for the serious injury of cardiac tamponade and the malfunction of map shift.

Manufacturer Narrative

It was reported that a patient underwent ventricular tachycardia (vt) ablation procedure using two (2) pentaray nav high-density mapping eco catheter, one (1) thermocool® smart touch® sf bi-directional navigation catheter and a carto 3 system and suffered a cardiac tamponade requiring pericardiocentesis and a product malfunction of a map shift with the carto 3 system.During mapping in the right atrium with pentaray nav high-density mapping eco catheter #1, the visualization of the spine became unstable.The visualization matrix had the spines going on and off even within the normal range.So, the cable was changed and the catheter was reconnected but the issue continued.When metal value was checked, value of the catheter which was connected to the 20a port was displayed over 1000.Then, the catheter was changed to pentaray nav high-density mapping eco catheter #2 and the issue improved but the phenomenon of intermittent disappearance of the pentaray nav high-density mapping eco catheter¿s spine continued.After that, it was confirmed that the acquired geometry and visitag were shifted diagonally and downward.On (b)(6) 2019, biosense webster inc.Received additional event information.It was reported that the physician commented that although there're no direct relationship with bwi product, the physician could not deny that the geometry and visitag shift affected the understanding the position and may have contributed to the adverse event.Intervention included pericardial drainage with the thoracotomy procedure.The adverse event was reported as occurred during ablation phase.The patient¿s diagnosis pre-procedure was ventricular tachycardia (vt) and it induced hemodynamic failure and needed direct current cardioversion during the procedure.In regard to the map shift, it was reported that the physician did not notice any error messages as the physician was trying to address the cardiac tamponade.The map shift occurred during the ablation and although cardioversion was performed the timing of the cardioversion is unclear.Carto 3 system device evaluation details: the device evaluation of the the carto 3 system has been completed.It has been concluded that per the additional event information received, the physician could not exclude that the map shift may have contributed to the ¿perforation¿ event.However, the physician also confirmed that the cardioversion was performed during the procedure alternately with mapping, therefore, the reported map shift was not related to the system malfunction.According to carto 3 instructions for use (ifu), when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.Furthermore, the physician couldn't notice whether there were any error messages as they were treating the patient for the cardiac tamponade.The related issue/event data files were requested for additional investigation, however, it was reported that the datat is no longer available as it was deleted during the system reimage performed during a service visit for an unrelated issue.The biosense webster inc.Field service engineer (fse) performed on site visit to perform a system evaluation.The reported catheter visualization issue was not duplicated.During visual inspection, the patient interface unit (piu) map port and u/s port were found physically damaged.This issue was not related to the reported issues.The damaged piu backplane card was replaced.A full system check was performed and no failure was found with the system.System was reported to be ready for use.A manufacturing record evaluation (mre) was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.The reported map shift issue has been determined to be related to a known 'map shift' issue.An internal corrective action has been open to investigate the issue.The issue with damaged piu ports has been determined to be is related to a known "damaged connectors on backplane cards" issue.An internal corrective action has been open to investigate the issue as well.Manufacturer¿s ref (b)(4).

Manufacturer Narrative

On (b)(6)2019, biosense webster inc.Received additional event information.It was reported that the physician commented that although there're no direct relationship with bwi product, the physician could not deny that the geometry and visitag shift affected the understanding the position and may have contributed to the event.Intervention included pericardial drainage with the thoracotomy procedure.The adverse event was reported as occurred during ablation phase.The patient¿s diagnosis pre-procedure was ventricular tachycardia (vt) and it induced hemodynamic failure and needed direct current cardioversion during the procedure.In regard to the map shift, it was reported that the physician did not notice any error messages as the physician was trying to address the cardiac tamponade.The map shift occurred during the ablation and although cardioversion was performed the timing of the cardioversion is unclear.Based on the additional information, the file remains mdr reportable.Additionally, the device manufacture date was received and therefore field h4 has been populated accordingly.Manufacturer¿s ref # pc-000544070.

Manufacturer Narrative

On 12/22/2019, a correction related to the h6.Results code has been processed.It was changed from code 213 (no device problem found) to code 4203 (electrical/electronic component problem identified) since the patient interface unit (piu) map port and u/s port were found physically damaged.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9144217
• MDR Text Key: 195523155
• Report Number: 2029046-2019-03711
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2; THMCL SMTCH SF BID, TC, D-F