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 Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto® 3 system and there was delay on the procedure leaving the physician concern on the potential risk to the patient.During procedure while ablation, a ¿patient moved, learn new¿ message appeared on the carto 3.An indifferent electrode was placed on the patient¿s leg however; this did not resolve the issue.Further on, force readings were high (70-100 grams) and an hi error was displayed, as well as the 12-lead ecg signals on both carto 3 and rs were almost lost of ecg signals when rf was applied.Troubleshooting was performed but the issues remained.The procedure was continued without resolving the issues.There was no patient consequence.This event was originally considered non-reportable, however, bwi became aware of additional information on (b)(4) 2015 that the procedure was completed by using a thermocool catheter as it did not have contact force characteristic.These were after switching smarttouch catheters and continue having the issues.Due to the delay of 45 minutes while the patient was under general anesthesia and physician considering that the delay caused a potential risk to the patient, this complaint was determined to be reportable.The awareness date for this record is (b)(6) 2015 because of the additional information received.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto® 3 system and there was delay on the procedure leaving the physician concern on the potential risk to the patient.During procedure while ablation, a ¿patient moved, learn new¿ message appeared on the carto 3.An indifferent electrode was placed on the patient¿s leg however; this did not resolve the issue.Further on, force readings were high (70-100 grams) and an hi error was displayed, as well as the 12-lead ecg signals on both carto 3 and rs were almost lost of ecg signals when rf was applied.Troubleshooting was performed but the issues remained.The procedure was continued without resolving the issues.There was no patient consequence.This event was originally considered non-reportable, however, bwi became aware of additional information on january 12, 2015 that the procedure was completed by using a thermocool catheter as it did not have contact force characteristic.These were after switching smarttouch catheters and continue having the issues.Due to the delay of 45 minutes while the patient was under general anesthesia and physician considering that the delay caused a potential risk to the patient, this complaint was determined to be reportable.The investigational analysis has been completed.The backplane card replaced.System running normally and is ready for use.Backplane was sent to device manufacturer (htc) for investigation.The tvs diode d1000 was found failed and has a low resistance which caused failure at 12 lead (bs) signals at ablation and problem "patient moved, learn new" (bs signals were unstable).A device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.The customer complaint was confirmed.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore no capa activity is required.

• 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: jaime chavez ; 9098398483
• MDR Report Key: 4479702
• MDR Text Key: 5329835
• Report Number: 3008203003-2015-00002
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1