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

Model Number M-4800-01

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a carto 3 system.An error 8 occurred and the acquired button was greyed out.They could not carry on pacing from the map and coronary sinus catheters.They were able to pace from the lasso catheter.It was planned pacing.They shut down the system and followed the steps which are written on carto ease application.After restarting, the system launched perfectly.However, after starting ablation, they had the same error and they shut down the system.They did not continue the procedure.The patient was under general anesthesia for two hours.A transseptal puncture had been performed.The physician considered cancelling the procedure caused a potential risk to this patient as they were not able to put ablation points.The patient did not require extended hospitalization and was sent home but would need to return after 1-2 months.There was no patient consequence.Since the procedure was cancelled because of product issue and the physician considered cancelling the procedure caused a potential risk to this patient, this event has been assessed as reportable.

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).

Manufacturer Narrative

Originally, it was reported in the 3500a report that the procedure was cancelled because of the product issue and the physician considered cancelling the procedure caused a potential risk to this patient.Therefore, this event had been assessed as reportable.Additional information was provided on april 6, 2015 correcting the information previously reported.The procedure was not cancelled.The physician decided to continue the procedure with the fluoroscopy system.The procedure was completed.The patient was well without any negative consequences.There was a 30 minute delay.However, the physician did not consider that the delay caused a potential risk to the patient.The issue was resolved with changing the cable after the procedure.Therefore, based on the new information received, the procedure was not cancelled and the physician did not consider there to be a risk to the patient.This event is reassessed as not reportable.(b)(4).It was reported that the error 8 was displayed by the system and the acquire button was greyed out.The bwi field service engineer reported that replacing the catheter cable resolved the reported issue.The bwi field service engineer also confirmed that the system was tested and passed all ecg tests.The system is ready for use.The device history record (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 (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4663093
• MDR Text Key: 21464332
• Report Number: 3008203003-2015-00018
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• 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
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1