MAUDE Adverse Event Report: BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); No Display/Image (1183); Malposition of Device (2616); Communication or Transmission Problem (2896)

Patient Problems Atrial Tachycardia (1731); Tissue Damage (2104); Complete Heart Block (2627)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

It was reported that during a persistent atrial fibrillation (afib) ablation procedure, there was noise on the intracardiac (ic) and ecg signals on both the carto 3 system and the bard recording system.The noise occurred on poles 1 and 2 of the lasso catheter.This issue was solved by replacing the catheter.During ablation, there was noise on poles 2, 3 and 4,5 of the new lasso catheter.Replacing the lasso catheter cable did not solve the noise.The noise was ultimately resolved by plugging the catheter into socket 20b rather than 20a.There was complete loss of signals approximately 3 hours into the procedure.This did not occur during ablation.This loss of signals occurred around six times during the last hour of the procedure and for no obvious reason.The signals usually came back within five seconds.There was severe noise on the ablation catheter.Replacing the all catheters and catheter cables did not resolve the issue.Upon request, additional information was provided on the event.The signal noise occurred on all the body surface (bs) ecg¿s and intracardiac (ic) signals on both the carto 3 system and the bard recording system at the same time.The degree of noise varied but at times it was impossible to read the signals.Most of the time, the physician was able to interpret the signals but sometimes the noise increased and then he was unable to interpret the signals.There was no obvious reason for why the noise occurred.It was not during ablation or after cardioversion.The procedure was abandoned.The physician thought there was a potential risk to the patient due to this malfunction.The severity of the noise on all the channels on both the carto 3 system and the bard recording system at the same time is indicative of a reportable event under the carto 3 system ((b)(4)).

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Concomitant product: 1.Lasso nav eco catheter /model #: d-1343-01-s / lot #: unknown_d-1343-01-s; 2.C3 external reference patch /model #: d-1283-02 / lot #: unknown_d-1283-02; 3.Coolflow tubing set / model #: d-1233-01-s /lot #: oem_d-1233-01-s.Biosense webster manufacturer's ref.Nos.(b)(4) are related to the same incident.(b)(4).In addition, the following patient event was also reported: the physician started by creating a left atrial geometry and doing a wide area circumferential ablation to isolate the left and right side pulmonary veins.After the veins were isolated, the atrial fibrillation turned into an atrial tachycardia.The physician then proceeded to map the left and right atriums to determine were the tachycardia was originating from.During mapping, there was intermittent loss of the ecg and intracardiac signals.The physician felt he might have ablated on or very close to the atrioventricular (av) node by mistake, causing a temporary heart block.After the temporary heart block, the physician decided that the procedure was too dangerous to continue.The patient remained in an atrial tachycardia as the physician was concerned about cardioverting him after the episode of heart block.The patient is being observed in a critical care unit over night.This procedure should have taken around 4 - 5 hours but due to the system problems the procedure was abandoned after 6 hours.Upon request, additional information was provided on the patient event.The patient was under local anesthesia.The procedure was performed in the left atrium.A transseptal puncture was performed prior to the procedure cancellation.The patient required extended hospitalization.The event was considered life threatening.The heart block was seen after the last burn of the procedure.Normal heart function did return after 1 minute.The damage was mild.No extra steps had to be taken after the procedure.The patient is being monitored overnight in a critical care unit.The patient is now fine.He may need a pacemaker if the heart block returns.The patient will need another procedure.The patient had a healthy baseline condition before the procedure apart from the episodes of atrial fibrillation.The patient event is being reported under the smart touch unidirectional catheter ((b)(4)).

Manufacturer Narrative

The 3500a report submitted on february 24, 2014 stated that the severity of the noise on all the channels on both the carto 3 system and the bard recording system at the same time was indicative of a reportable malfunction event which was reported under the carto 3 system (pi1-jaxm1x).In addition, the patient event was reported under the smart touch unidirectional catheter (pi1-jsfb2v).On july 30, 2014, the medical safety officer assessed this event as follows: after discussion of the events of the case and narratives, including the quality engineering reports, the carto malfunction with noise on all signals most likely led to the result of the heart block.On a normal electrogram using the lasso catheter, if the electrodes are near the bundle of his, the electrogram signals should show the h signal if the electrodes are in close proximity to the structure.Because of the noise issue, the operator was unable to determine if they were in close proximity to the bundle of his.Because the noise issue, it obscured the h signal and the operator ablated around the region, thus causing heart block.Therefore, he believes the noise issue obscured the his signals and led the operator to believe they were not in close proximity and led to them ablating the region, thus causing heart block.Per the re-assessment by the medical safety officer on july 30, 2014, the carto 3 system (pi1-jaxm1x) complaint was re-assessed from malfunction to serious injury.(b)(4).

Manufacturer Narrative

Manufacturer's ref.No.: (b)(4).It was reported that during a persistent atrial fibrillation (afib) ablation procedure, there was noise on the intracardiac (ic) and ecg signals.The bwi field service engineer arrived on site for troubleshooting and repair.The bwi field service engineer replaced the backplane and the ecg card.The noise issues were solved.All atp tests were performed and passed.The system was ready for clinical use.The parts were sent to the haifa technology center (htc).The backplane card was tested and the reported problem was found at the ecg card.Thee optocoupler u448 on the ecg card was found faulty which caused the reported problems.The ecg card was upgraded.An additional oem manufacturer action device history review (dhr) was performed.No anomalies were noted in manufacturing or service.An internal corrective action has been opened to address the issue related to ¿opto switches and tvs failures.¿.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3643280
• MDR Text Key: 4348562
• Report Number: 3008203003-2014-00013
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening