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

Model Number M-4800-01

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226)

Event Date 06/24/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6), female, underwent an idiopathic ventricular tachycardia (vt) ablation procedure with a carto 3 mapping system and suffered a cardiac tamponade which required pericardiocentesis.The patient had no reported medical history that contributed to the event.During the procedure, the carto 3 mapping system froze as the physician attempted to map the location of the catheters inside of the heart.To troubleshoot the software issue, the workstation was rebooted; the case was reopened and continued.There was a noticeable map shift error of at least 10 mm that occurred when attempting to create maps utilizing cartosound and paso software on the carto mapping system.The physician then noticed that the patient¿s blood pressure was decreasing and diagnosed a pericardial effusion using intracardiac echocardiography (ice) and believes that one of the catheters in place must have caused a perforation.The procedure was aborted.A pericardiocentesis was performed to remove 150 ml of fluid and a pigtail catheter was put in place to allow drainage.The patient did not require hospitalization and fully recovered with no residual effects.The physician¿s opinion regarding the cause of this adverse event is that this event may be due to a diagnostic medtronic marinr quad catheter that was also being used during the event, as he believes it may have perforated the heart.Nonetheless, this event is being reported under the carto 3 system because such reported map shift may contribute to potential patient risk.This event was also reported to the fda under the bwi thermocool catheter (as a separate report).The bwi failure analysis has begun but is not completed at this time.

Manufacturer Narrative

When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant products: stockert 70 (serial # (b)(4), model# m-5463-01).Coolflow pump (serial # (b)(4), model# m-5491-02).Soundstar® 3d diagnostic ultrasound catheter (model # m-5723-12).Decanav¿ electrophysiology catheter (model#, d-1283-02-s, lot number unk).Thermocool® smarttouch® bi-directional navigation catheter (model # d-1327-04-s, lot # 16086430m) (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient, (b)(6) female, underwent an idiopathic ventricular tachycardia ablation procedure with a carto 3 mapping system and suffered a cardiac tamponade which required pericardiocentesis.The investigational analysis has been completed.Carto 3 system was replaced and suspicious system was sent to htc for investigation: the customer complaint was not confirmed.The system passed atp at service jig utility station and was tested at aquarium station with a few types of catheters (uls and st).Workstation was tested by sw department and csd to dig up some more information from this case and it was found that the data has been deleted on prior to shipment at htc to fulfil the hipaa requirement.No dump file or recordings were saved on the workstation, so further investigation couldn't be performed.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.Out of 4 additional reported complaints there was no any additional complaint that may be related to the reported issue.A 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, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3935106
• MDR Text Key: 4599250
• Report Number: 3008203003-2014-00049
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2014
• 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
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 48 YR