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

Model Number M-4800-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system and the visitag's disappeared.Error 19 (failure in the ecg1 card) was seen randomly during the procedure, after rf application was started.The user could not take points, but visitag's were still appearing as desired.They rebooted the patient interface unit (piu) and the error cleared.However, most of the visitag's disappeared once the system re-initialized and respiratory gating was reset.Changing the settings under the visitag tools resulted in the loss of more of the tags taken prior to the reboot.The physician did not want to perform more trouble shooting at this time.The procedure was completed without patient consequence.The bit error issue was assessed as not reportable.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the visitag¿s disappeared and should reappear after reinitializing.

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

Evaluation summary: (b)(4).It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto 3 system and several issues were seen during this procedure.A "current leak¿ error was seen on the carto 3 system.After extensive trouble shooting, the issue was determined to be a bad reprocessed pentaray nav eco cable.The pentaray itself was also noted to have 2 bad electrodes, 13, 14 that were black colored on the c3 ws display.It was reported that exchanging the pentaray navigational eco catheter resolved these issues.It was also reported that an ecg card 1 "bit error" was seen randomly during the procedure, after radiofrequency application was started.The user could not take points, but visitag's were still appearing as desired.The user rebooted the patient interface unit (piu) and the error cleared.However, most of the visitag's disappeared once the system re-initialized and respiratory gating was reset.Changing the settings under the visitag tools resulted in the loss of more of the tags taken prior to the reboot.The physician did not want to perform more trouble shooting at this time.The procedure was completed without patient harm.Re-initialization of system and reset respiratory gating caused disappearing of visitag¿s taken prior to the reboot.This is a normal behavior of system application.The bwi field service engineer contacted the bwi field representative regarding the bit failure error and confirmed that as the issue was not duplicated the service was declined.System is operational.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: 4800655
• MDR Text Key: 5927030
• Report Number: 3008203003-2015-00036
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1