MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00C

Device Problem Signal Artifact/Noise (1036)

Patient Problem Tissue Damage (2104)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

It was reported that during an ablation procedure, the signal of the mapping catheter had noise in carto system and ep recording system.The issue persisted after replacing the mapping catheter extension cable and body surface cable (this issue is not reportable event).The customer had to stop the carto 3 procedure since the physician considered the noise was a potential risk to the patient, making this event reportable.The patient was under local anesthesia and a transseptal puncture was performed.The patient was transferred to other hospital and operated.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Refer to evaluation summary (b)(4).It was reported that during an ablation procedure, the signal of the mapping catheter had noise in carto system and ep recording system.The issue persisted after replacing the mapping catheter extension cable and body surface cable (this issue is not reportable event).The customer had to stop the carto 3 procedure since the physician considered the noise was a potential risk to the patient, making this event reportable.The patient was under local anesthesia and a transseptal puncture was performed.The patient was transferred to other hospital and operated.The investigation indicated the issue was related to user error hw and software set up.Several actions were taken for resolving the issue: managed cable and lab room device (managed the power cable of the cart and body surface cable and any device close to the patient table moved away.Re-set up the ecg filter channel (high channel filter channel set up to 60).In addition the user replaced the cable connect to the stockert which is 39d-43r and replace the new patch (the new patch is connect to the stockert, indifferent patch electrode cable).These cables are not related to carto.The system works fine and the problem is solved.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: SIMILAR DEVICE FG540000, 510K # K042999
• 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 ; 9098398483
• MDR Report Key: 4513098
• MDR Text Key: 5489180
• Report Number: 3008203003-2015-00005
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-5400-00C
• Device Catalogue Number: FG540000C
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1