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

Model Number M-4800-01

Device Problem Failure to Align (2522)

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

Event Date 07/27/2017

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 a patient underwent a procedure for left atrial tachycardia with a carto 3 system where a map shift occurred.During the procedure, multiple map shifts occurred, each about 2 cm.A catheter snapshot of the coronary sinus was taken prior to the first map shift.Then, a new map was created, and another map shift occurred 5 minutes later.No error messages displayed.No cardioversion was performed, and the patient did not move.The procedure was completed with the same carto 3 system.No patient consequences were reported.A map shift with no error message can potentially be caused by a system malfunction, presenting a potential risk to the patient.As a result, this event is mdr reportable.

Manufacturer Narrative

Manufacturer's reference number: (b)(4) it was reported that a patient underwent a procedure for left atrial tachycardia with a carto 3 system where a map shift occurred.The field service engineer reported that the issue was related to patient movement, and was never duplicated.The customer declined service because the issue was not duplicated during the next procedure the same day.The system is operational.A device history record (dhr) review was performed by the manufacturer, and no anomalies related to the reported issue were noted in the manufacturing or servicing of this equipment.The customer complaint could not be confirmed.

• 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 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6798229
• MDR Text Key: 83632362
• Report Number: 3008203003-2017-00030
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1