MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000

Device Problems No Fail-Safe Mechanism (2990); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

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 paroxysmal atrial fibrillation (afib) procedure with a carto 3 system.During mapping, it was reported that a map shift occurred on the carto 3 system.The procedure was completed with no patient consequence.Response received stated that there were no error/warning messages displayed on the carto 3 system.The position of the catheter did not correspond with the real position of the catheter in the heart.The difference in catheter location before and after map shift was 1.5 cm.It was also confirmed that no cardioversion was performed prior to the map shift.There was no evidence of patient movement.This map shift with no error/warning message was assessed as a reportable malfunction as it could potentially be caused by a system malfunction and therefore was a potential risk to the patient.

Manufacturer Narrative

The device history record review was provided on (b)(6) 2017.The dhr review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer's ref.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system.During mapping, it was reported that a map shift occurred on the carto 3 system.The procedure was completed with no patient consequence.Response received stated that there were no error/warning messages displayed on the carto 3 system.The position of the catheter did not correspond with the real position of the catheter in the heart.The difference in catheter location before and after map shift was 1.5 cm.It was also confirmed that no cardioversion was performed prior to the map shift.There was no evidence of patient movement.All tests were performed successfully after the map shift.No problem was found.Map shift was not reproduced during the next cases.The system is working according to specifications.According to the carto 3 instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer's ref.No: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA ; IS
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA ; IS ; 949789-383
• MDR Report Key: 6845514
• MDR Text Key: 85000672
• Report Number: 3008203003-2017-01004
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2017
• 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