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

Model Number M-4800-01

Device Problems Over-Sensing (1438); Failure to Select Signal (1582)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a left atrial flutter procedure with a carto® 3 system and experienced noise and loss of signals on all electrocardiograms (bodysurface and intracardiacs) at carto and electrophysiology recording system.No further information is known regarding the patient status.This event is being reported because the lack of cardiac rhythm monitoring while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

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.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

Evaluation summary.(b)(4).It was reported that a patient underwent a left atrial flutter procedure with a carto® 3 system and experienced noise and loss of signals on all electrocardiograms (bodysurface and intracardiacs) at carto and electrophysiology recording system.No further information is known regarding the patient status.This event is being reported because the lack of cardiac rhythm monitoring while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.The investigational analysis has been completed.Fse spoke with local cas and was informed that the customer does not request fse visit to investigate the root cause of the noise as the lab is under reconstruction and ep-system is going to be replaced soon.In case issue is not resolved after lab move in q4 customer is going to request additional service.The customer is not willing to perform trouble shooting at the moment.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.5 out of 9 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: 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: shahe garabedian ; 9098397362
• MDR Report Key: 4798264
• MDR Text Key: 18894608
• Report Number: 3008203003-2015-00035
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/06/2015

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: 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: 05/06/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1