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); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the carto 3 system had a message window come up on the screen stating, "warning, there is a voltage leak detected on your system, please unplug all cables from the patient interface unit (piu)." the message was there for about 10 seconds then went away.The message appeared again for about a minute and then went away again.While the message was on the screen, the body surface (bs) ecg was very noisy (60 cycle).The physician proceeded with the procedure.The message did not reappear.There was no patient injury reported.Upon request, additional information was provided on the event.The noise was on all bs and intracardiac (ic) recordings on both the carto 3 system and the recording system at the same time.Everyone in the lab noticed the noise.The noise lasted for approximately 30 seconds.The catheters were not inserted yet, but the ecg could not be interpreted appropriately.The noise occurred as the physician was gaining access.The additional information stating the severity of the noise on all the bs and ic recordings on both the carto 3 system and the recording system at the same time is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during an atrial fibrillation (afib) procedure, the carto 3 system had a message window come up on the screen stating, "warning, there is a voltage leak detected on your system, please unplug all cables from the patient interface unit (piu)." the message was there for about 10 seconds then went away.The message appeared again for about a minute and then went away again.While the message was on the screen, the body surface (bs) ecg was very noisy (60 cycle).The physician proceeded with the procedure.The message did not reappear.There was no patient injury reported.The bwi field service engineer spoke to the bwi field representative.The bwi field representative said that the error came up for 10 seconds and then went away.It came up again for 15 seconds and then went away.The physician wanted to proceed with the procedure.The error did not come up again.They had a procedure after and the error did not come back.The issue was not duplicated.In addition, the complaints after this event that were associated with this specific system were reviewed as well and there were no additional complaints related to the reported issue.An additional oem manufacturer action (device history review-dhr review or investigation) was performed.No anomalies were noted in manufacturing or service.

• 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: 3618242
• MDR Text Key: 4160318
• Report Number: 3008203003-2014-00008
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• 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: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1