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

Model Number M-4800-01

Device Problems Signal Artifact/Noise (1036); Noise, Audible (3273)

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

Event Date 10/24/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and there was noise presented on all electrocardiograms, but still there was available signal to monitor patients heart rhythm on defibrillator and anesthesia monitor, however, procedure was cancelled without patient consequence.Settings during the event include: temperature cut-off at 45 celsius degrees and impedance of 150 ohms.This event is being reported because physician did consider that cancelling the procedure could cause a potential risk to this patient.

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

Evaluation summary.Manufacturer¿s reference #: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and there was noise presented on all electrocardiograms, but still there was available signal to monitor patients heart rhythm on defibrillator and anesthesia monitor, however procedure was cancelled without patient consequence.The investigational analysis has been completed.Fse contacted the caller for details, but was advised that she does not have additional information since she was not on site and customer reported everything to her after it happened.Fse followed up with the account.The customer performed a case after the reported issue.This time there was no noise on the signals and the system showed no errors.They were able to complete the case with no problems.According to the caller, probably the catheter was the problem.The issue was not duplicated.System is operational.The history of customer complaints associated with carto 3 system # 12690 was reviewed.Out of 2 additional reported complaints there was no any additional complaint that 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 (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
• MDR Report Key: 4272783
• MDR Text Key: 21721556
• Report Number: 3008203003-2014-00076
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/27/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1