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

Model Number M-4800-01

Device Problems Application Program Problem: Parameter Calculation Error (1449); Failure to Align (2522)

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

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

The ¿suspected medical device¿ of "carto 3 system version 6" reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to carto 3 system approved under k133916.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 an atrial fibrillation (afib) procedure with a carto 3 system.During mapping, there were two map shifts of at least 1 cm with no error messages.There was also no cardioversion performed and no patient movement prior to these map shifts.Remapping was performed and the issue was resolved.The procedure was completed with no patient consequences.This issue has been assessed as a reportable malfunction as such map shifts without an error message could potentially be caused by a system malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.During mapping, there were two map shifts of at least 1 cm with no error messages.There was also no cardioversion performed and no patient movement prior to these map shifts.Remapping was performed and the issue was resolved.The procedure was completed with no patient consequences.Issue was investigated by the device manufacturer and it was found that after a short time since the study was started there was movement of the upper part of the patient torso which is not recognized by the back patch.It resulted with a ~13 mm shift of the chest patch average position while the back patch did not move.Map shift issue is documented in the instructions for use (ifu) when there is not any movement of the back patches however the patient moved in such a way as to cause a shift in the heart's anatomical position.Issue was not duplicated next cases.The device history record (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 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6198284
• MDR Text Key: 63489749
• Report Number: 3008203003-2016-00047
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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: 11/24/2016
• 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