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

Model Number FG-5400-00M

Device Problems Pacing Problem (1439); Noise, Audible (3273)

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

Event Date 11/27/2015

Event Type  malfunction  

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).

Event Description

It was reported that during an afib.Ablation procedure, pacing could not be obtained with red black pacing cable.The issue was resolved by replacing cable.Multiple attempts have been made to obtain clarification to this issue.However, no further information has been made available.With the information available at present, bwi takes conservative approach to report this event as the pacing cable may affect the functionality of the direct pacing port and failure of the direct pacing port could potentially delay patient treatment.It was also reported two mdr non-reportable issues occurred during the same procedure.The indifferent electrode was attached on the patient body but blinking was not disappeared.The issue was resolved by replacing the indifferent electrode.A signal noise occurred at electric potential of the smart touch catheter.The issue was resolved by replacing catheter.The procedure was successfully completed without patient's consequence.

Manufacturer Narrative

(b)(4).It was reported that after the patient entered operation room, the indifferent electrode attached on the patient body was blinking and not disappeared.The issue was resolved by changing the indifferent electrode to another one.It was confirmed the cable of the indifferent electrode was disconnected.It was confirmed that the valley lab patch cable is faulty and it was replaced with a new one.The issue was resolved.It was also reported that the signal noise occurred at electric potential of the smart touch catheter.The cable and connection port was changed but the issue continued.The issue was improved once by changing the catheter to another one.But the issue reoccurred.The issue was resolved by changing the catheter to another one.It was also reported that furthermore the pacing could not be obtained with red black pacing cable.The issue was resolved by changing the cable to another one.The procedure was successfully completed without patient's consequence.It was confirmed that the pacing cable is faulty and it was replaced with a new one.The issue resolved and the system is operational.The history of customer complaints associated with carto 3 system # 50132 was reviewed.There was no any additional complaint out of 6 additional reported complaints that may be related to the reported issue.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 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5317051
• MDR Text Key: 34777614
• Report Number: 3008203003-2015-00099
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: FG-5400-00M
• Device Catalogue Number: FG540000M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1