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

Model Number M-4800-01

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem Ventricular Tachycardia (2132)

Event Date 10/02/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure that utilized a carto 3 system and suffered a ventricular tachycardia.During the procedure, the physician noticed that the ecg surface had disappeared from the carto 3 system display.Multiple system errors were generated, some of which indicated that the system should be shut down and some linked to body surface (bs) ecg recordings.Although multiple attempts have been made to obtain clarification to this complaint, no further information has been made available.Thus, it is not clear from all follow-ups performed, how, why or when the patient suffered a ventricular tachycardia.The awareness date for this complaint was reset to (b)(4) 2014, the date we were made aware that the patient suffered a ventricular tachycardia.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: unk.(b)(4).The investigational analysis has been completed.The bs ecg cables were replaced and the issue has been resolved.

Manufacturer Narrative

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 (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: 4354339
• MDR Text Key: 5205846
• Report Number: 3008203003-2014-00080
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other