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

Model Number M-4800-01

Device Problems Leak/Splash (1354); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the field service engineer (fse) arrived to the account and performed advanced catheter location (acl)/electrocardiogram (ecg) testing.The system passed all of these tests and the current leakage problem could not be duplicated.As a preventive measure, the fse replaced the body surface ecg cable.The fse was later told that the next case had no issues or problems, and that the system was operational.A device history record review was performed by the manufacturer and no anomalies were noted in the manufacturing or servicing of this equipment.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system when a current leak error message was displayed, causing a complete signal loss on all three systems in use (carto, recording system, anesthesia monitor), as well as the appearance of an abnormal heart rhythm (ventricular fibrillation [v-fib]) on the anesthesia monitor.A blood pressure monitor was also in use at the time, and was used to determine that the patient was not in v-fib.The end user changed the catheter and was also instructed to change the cables, but only a limited number were available, and none of them were new.The end user was then instructed to replace the catheter a second time, but the issue was ultimately resolved by reseating the original cable.The case was then completed with no patient consequences using the same equipment.The inability to monitor a patient's cardiac rhythm while devices are inside the heart can lead to an undetected rhythm that may be life threatening.The staff was unable to determine the patient's cardiac rhythm using electrocardiogram signals, and as a result, this issue is mdr reportable.

• 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: 5844993
• MDR Text Key: 52387959
• Report Number: 3008203003-2016-00029
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1