MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Model Number FG-5400-00J

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 02/02/2015

Event Type  Injury  

Event Description

It was reported that during atrial tachycardia (at) procedure, several errors came up during initialization of system.Troubleshooting and exchange of catheters and cables was not successful.The patient was high risk and under general anesthesia with a difficult intubation.The procedure lasted 5 hours and was completed successfully without the use of carto.The patient was transferred to icu and required extended hospitalization.The physician considered that the case delay caused a risk to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during atrial tachycardia (at) procedure, several errors came up during initialization of system.Troubleshooting and exchange of catheters and cables was not successful.The patient was high risk and under general anesthesia with a difficult intubation.The procedure lasted 5 hours and was completed successfully without the use of carto.The patient was transferred to icu and required extended hospitalization.The physician considered that the case delay caused a risk to the patient.Patch unit was replaced however there was no resolution.Piu and location patch were replaced and the problem was resolved.The suspicious parts were sent to the carto manufacturer (htc) and it was stated that the customer's complaint was confirmed.The issue was caused by the faulty loc rx card (part of piu) and no problem was found with lp.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: SIMILAR DEVICE FG540000, 510K # K042999
• 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: jaime chavez ; 9098398483
• MDR Report Key: 4523583
• MDR Text Key: 5545113
• Report Number: 3008203003-2015-00007
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-5400-00J
• Device Catalogue Number: FG540000J
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization