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

Model Number M-5830-01

Device Problems Device Displays Incorrect Message (2591); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

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 procedure with a carto 3 rmt system and a system crash occurred.The carto 3 rmt workstation crashed early into the procedure with minimal data having been acquired and a message of "study must close" appeared.During this crash, the physician was in the process of performing a transseptal puncture and the ultrasound image was lost on both the carto 3 rmt system and ultrasound machine.Despite the crash and loss of imaging, the patient was not harmed.The user was able to recover the case without data loss.The procedure was completed without patient consequence.This issue of system crash and image loss would not normally be mdr reportable, however since it happened during the transseptal puncture, which is a risky portion of the procedure in which the physician relies on ultrasound imaging for guidance; this event has been assessed as mdr reportable.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 rmt system and a system crash occurred.During this crash, the physician was in the process of performing a transseptal puncture and the ultrasound image was lost on both the carto 3 rmt system and ultrasound machine.The user was able to recover the case without data loss.The loss of the ultrasound image was caused by the workstation crash.As a soundstar catheter can be used only when connected and identified by an active carto system, the carto 3 workstation crash brought the disappearance of ultrasound video display on the ultrasound machine.This is an expected system behavior described in the carto® 3 ifu: "if power to the carto® 3 system is disrupted (including during piu or workstation restart), the ultrasound image is not displayed on the ultrasound machine until the carto® 3 system is restored.Ensure that alternative imaging tools for monitoring serious adverse events, such as transthoracic or transesophageal echocardiography, are available in case of disruption of power to the carto® 3 system".The field service engineer spoke to the bwi representatives and it was relayed that the customer has decided not to have anything done at this time.The customer refused service.The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.The issue is related to an internal corrective action for the ultrasound image disappearing after crash issue.

• Brand Name: CARTO 3 RMT 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: 5795161
• MDR Text Key: 50532043
• Report Number: 3008203003-2016-00027
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

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-5830-01
• Device Catalogue Number: FG560000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1