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

Model Number M-4800-01

Device Problems Electromagnetic Interference (1194); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.There was a metal interference error which caused the procedure to be cancelled.There was no patient consequence or extended hospitalization.Upon clarification, the patient was under local anesthesia and a transseptal puncture had been performed.The physician considered cancelling the procedure caused a potential risk to the patient as he was half way through with the procedure, had to continue without the guidance of the carto 3 system and was unable to induce the required ventricular tachychardia.However, electrophysiology (ep) labs are equipped with many complex systems connecting one to another and to the patient, such as fluoroscopy systems or air conditioning systems.This lab equipment can cause severe distortion to the magnetic field.This error is highly detectable and not a malfunction, but since the physician considered it a possible risk to the patient and cancelled the procedure this is mdr reportable.

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.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.There was a metal interference error which caused the procedure to be cancelled.There was no patient consequence or extended hospitalization.After further follow up, the customer said that when booting the system it was returning error #503 (noise on the location pad currents).Trying with a spare location pad cable did not help.It was not possible to do any troubleshooting since issue was not reported live.After 4 initializations failed, the system showed error#17.The bwi field service engineer (fse) arrived on site for troubleshooting and repair.Location pad and mag tx card were replaced.Atp test carried out as part of repair.All tests passed.Issue resolved.System is ready for use.The suspicious parts were sent to device manufacturer.Device manufacturer reported: the customer complaint was confirmed.The location pad found failed: magnetic channels 4 and 5 found failed.The diodes u9 and u10 failed.Mag tx card found operable.A device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to address this issue.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4167661
• MDR Text Key: 5025951
• Report Number: 3008203003-2014-00067
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• 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
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• 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: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1