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

Model Number M-4800-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/15/2016

Event Type  Injury  

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.Concomitant product: thermocool sf smarttouch bi-directional catheter (model# d-1348-05-s).St jude medical crd cs catheter 6fr (lot# 5659483).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered a cardiac tamponade requiring medical and surgical intervention.During the mapping phase, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram.Patient was transferred to the operating room for open chest exploratory surgery.Patient was reported to be in stable condition.The patient required extended hospitalization as a result of this adverse event for recovery from surgery.Since then, the patient¿s outcome has improved.There were no patient factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to a possible carto 3 system advanced catheter location (acl) misrepresentation of the location of the st.Jude medical coronary sinus (cs) catheter.The acl displayed the cs catheter to be in the superior vena cava (svc), when it was in the cs.No troubleshooting was performed.Transseptal puncture was performed with an unspecified needle.St.Jude medical agilis sheath was used.Generator settings were not reported.Patient received anticoagulant during the procedure with activated clotting times maintained at greater than 350 seconds.No bwi catheters were identified as being related to the adverse event.There were no errors reported by the biosense webster systems.Coronary sinus catheter was non-bwi.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto® 3 system and suffered a cardiac tamponade requiring medical and surgical intervention.Physician¿s opinion regarding the cause of the adverse event is that it was related to a possible carto 3 system advanced catheter location (acl) misrepresentation of the location of the st.Jude medical coronary sinus (cs) catheter.The acl displayed the cs catheter to be in the superior vena cava (svc), when it was in the cs.Field service engineer (fse) visited the account regarding this issue.It was found that the issue was caused by a faulty non-biosense webster inc.(bwi) catheter.The catheter was not saved.Additional information received indicated that no bwi products were determined to be at fault.Fse completed atp tests per customer's request.All tests passed.System is up and ready for use.Device history record 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: 6173880
• MDR Text Key: 62359872
• Report Number: 3008203003-2016-00043
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention