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

Model Number M-4800-01

Device Problems Accessory Incompatible (1004); Improper or Incorrect Procedure or Method (2017); Electro-Static Discharge (2149)

Patient Problem Electric Shock (2554)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a carto 3 system and an electric shock device malfunction occurred.It was reported that there were several issues on the carto 3 system.The patient arrived in the operating room in atrial fibrillation which they succeeded in organizing in atrial tachycardia.During the procedure, the physician wanted to change his catheter from a blue thermocool to an orange thermocool.He did not realize that his staff gave him a smart touch catheter instead of an orange thermocool.When he tried to connect the smart touch catheter to the previously used (wrong) extension cable, the patient received an electric shock at the location of the tip of the catheter.The physician realized that the catheter connector did not fit in the cable.After connecting the correct catheter to the correct cable, he received an error 40 "map: defective catheter or cable." they changed the mapping cable three times before the error went away.After eight hours in the procedure, the physician decided to end the procedure with a cardioversion which put the patient back in sinus rhythm.However, the patient was back again in at the next day.There were no patient consequences, apart from the patient being confused and more stressed during and after the procedure because of the technical problems.The patient did not require extended hospitalization nor intervention.The physician believes the electric shock was due to the bad connection.

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.In the thermocool smart touch uni-directional navigation catheter instructions for use (m-5276-693e) under the directions for use it provides the proper steps for connection of the catheter and cable.It states to connect the catheter to the patient interface unit (piu) via the appropriate biosense webster cable.After, insert the catheter into the entrance site.(b)(4).

Manufacturer Narrative

(b)(4).During the procedure, the physician changed the catheter from a blue thermocool to an orange thermocool.He didn't realize that his staff gave him a smart touch instead of an orange thermocool.When he tried to connect the smart touch catheter to the previously used (wrong) extension cable, the patient received a shock and the physician realized that the catheter connector did not fit in the cable.This issue is related to user error.The user tried to connect the catheter that does not match the extender cable.The connection between the two of them is impossible and only by adding mechanical strength.Also, after connecting the correct catheter to the correct cable, he got error 40 "map: defective catheter or cable." the mapping cable was replaced and the issue was resolved.They could finish the procedure without consequences for the patient.The system was checked.Full atp test was performed and passed.The system is up and running.It is ready for use.A 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: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4042875
• MDR Text Key: 4803648
• Report Number: 3008203003-2014-00057
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/29/2014

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: 07/29/2014
• Initial Date FDA Received: 08/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1