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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/27/2014

Event Type  malfunction  

Event Description

It was reported during an afib - paroxysmal that error 8 appeared on the carto3 system when the ablation catheter was connected, the signal noise occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) recordings on both carto and ep recording systems at the same time and a red light on ecg card # 3 on back of piu.The physician did not have at least one signal available to monitor patient heart rhythm.The customer exchanged the ablation cable and rebooted the piu without resolution (when the cable was disconnected the noise resolved).Advised a full system reboot without catheters connected, the system fully initialized when a new study was started, error 8 did not return.Advised reconnecting ecg cable, connecting a new map cable (only reprocessed available), and connecting a new map catheter.Error 8 did not return and signals were clean on both carto and ep recording systems.The case was completed without any patient consequence.

Manufacturer Narrative

The hardware investigation is still in progress.A supplemental report on device evaluation will be submitted.(b)(4).

Manufacturer Narrative

Multiple attempts were done to request for further details of the mapping catheter.However no additional information has been provided.Refer to evaluation summary manufacturer ref #(b)(4).It was reported that error 8 appeared on the carto 3 system when the ablation catheter was connected, with noisy ecgs on carto 3 and ep recording systems, and a red light on ecg card 3 on back of piu.A physician couldn¿t interpret the both bs ecgs and all ic recordings signals.Once a new map catheter was connected to the system, error 8 did not return, and signals became clean on both systems carto 3 and ep recording systems.The system is ready for use.The issue was related to defective map catheter.The history of customer complaints associated with carto 3 system # 11666 was reviewed.One out of 38 additional reported complaints may be related to the reported issue.A dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• 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: 3878326
• MDR Text Key: 4512168
• Report Number: 3008203003-2014-00044
• 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: 05/27/2014

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: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1