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

Model Number M-4800-01

Device Problem Device Alarm System (1012)

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

Event Date 01/25/2017

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 an atrial fibrillation (afib) procedure with a carto 3 system.At the beginning of the procedure and after inserting the catheters, a map shift without error message on the carto 3 system was noted after attempting to utilize the univu feature.The lasso catheter was approximately 2cm out of range.The physician had images of the siemens system and based on the anatomical structure and placement of the catheters he could corroborate the correct catheter position.The procedure was completed with no patient consequence.There was no patient movement or cardioversion that took place prior to map shift.Therefore, this event has been assessed as a reportable malfunction as such map shifts without an error message could potentially be caused by a system malfunction, and there would be a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.At the beginning of the procedure and after inserting the catheters, a map shift without error message on the carto 3 system was noted after attempting to utilize the univu feature.The lasso catheter was approximately 2 cm out of range.Issue was related to user error work flow.The mismatch described on the complaint occurred because of a specific workaround where no map was build but the segmented volume was used.This sensitive workflow can have mismatch issues due to location pad movement and wrongly placed segmented volume on rotational angiography.The system was tested and was found functioning correctly and ready for use.It was explained to the customer that the system is tested and working according to the system specification and this issue was not duplicated in the next cases.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.

• 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: 6331628
• MDR Text Key: 67851917
• Report Number: 3008203003-2017-00006
• 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
• Report Date: 01/25/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• 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