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

Model Number M-4800-01

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia procedure with a carto 3 system and a map shift ¿ no error message device malfunction occurred.During mapping, there was a position mismatch of about 3cm on the catheters in relationship between the carto 3 system and the actual fluoro system.The map shift was discovered by reviewing against fluoro.The cpm was completely built around the catheters.There were no metal warnings or errors.The physician continued the procedure conventionally.No additional troubleshooting was possible.There was no patient consequence.

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)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent a supraventricular tachycardia procedure with a carto 3 system and a map shift ¿ no error message device malfunction occurred.During mapping, there was a position mismatch of about 3cm on the catheters in relationship between the carto 3 system and the actual fluoro system.The map shift was discovered by reviewing against fluoro.The cpm was completely built around the catheters.There were no metal warnings or errors.The physician continued the procedure conventionally.No additional troubleshooting was possible.There was no patient consequence.The bwi field service engineer spoke to the customer about the reported issue.They do not want an bwi field service engineer to visit as this is a billable system.According to the customer, the bwi field representative will be onsite for a procedure and will follow up with the bwi field service engineer.The bwi field service engineer spoke to the bwi field representative that was onsite for a procedure and the reported issue was not duplicated.The system is fully functional.No service is needed or requested.A device history record (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: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: 4082904
• MDR Text Key: 4825718
• Report Number: 3008203003-2014-00060
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 08/15/2014

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: 08/15/2014
• Initial Date FDA Received: 09/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1