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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and experienced map shift without system providing an error message.The procedure was completed without patient consequence.This event is being reported because issue of this type could potentially contribute to an adverse event.

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

Manufacturer's reference #: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and experienced map shift without system providing an error message.The investigational analysis has been completed.Issue was not duplicated.The provided data is lack with information, based on the available information the root cause of the failure cannot be determined.In addition this report submitted for documentation purposes only.A follow up with the customer indicated no further map shift incidents have been experienced.The carto system continues to work well.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.Out of (b)(4) 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
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4372267
• MDR Text Key: 5233720
• Report Number: 3008203003-2014-00082
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/22/2014

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: 12/19/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1