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

Model Number M-4800-01

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia procedure with a carto 3 system and a high impedance occurred which lead to the procedure being cancelled.It was reported that the impedance was consistently high.The thermocool sf bidirectional catheter, catheter cable, redel cable, stockert generator, indifferent electrode cable and grounding pad were replaced with no resolution.Impedance values showed from 200 to 300 ohms.The stockert redel adapter was not replaced.The piu was rebooted without resolution.The case was subsequently cancelled.Upon request additional information was received on the event.The patient was under local anesthesia.A transseptal puncture was performed prior to the case cancellation.The maximum impedance cutoff was set at 250 ohms and the system stopped when the impedance cutoff value was exceeded.No ablations were actually done because the impedance in the ventricle was 270-300 ohms so the impedance max was already exceeded.Settings include: power control mode 50 watts / temperature cutoff 40 degrees celsius.The high impedance values that were displaying were thought to be false.Even after switching everything involved out, the impedance values were still high and could not be trusted.Therefore the physician was not comfortable in continuing with such high impedance and it was then thought the high impedance could possibly be related to the patient condition.The patient has still not been brought back.Since the physician felt that it was unsafe to complete the procedure and this was a high risk patient, the case cancellation is indicative of a reportable event.

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 an ischemic ventricular tachycardia procedure with a carto 3 system and a high impedance occurred which lead to the procedure being cancelled.Field service engineer met with the local bwi representative and they set up the wet bath and confirmed the system is working properly.The stockert and the carto 3 system were both showing the same impedance of 45 - 50 ohms.The issue was not duplicated.The conclusion is the issue was patient specific.The system is ready for use.The history of customer complaints associated with this carto 3 system was reviewed.There was not any additional reported complaints that may be related to the reported issue.Device history record 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 2066 717; 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: 4838497
• MDR Text Key: 18010031
• Report Number: 3008203003-2015-00041
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• 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: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1