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

Model Number M-4800-01

Device Problems Radio Signal Problem (1511); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/25/2015

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.It was reported that the 12 leads have low amplitude on the carto 3 system and ep recorder.The ecg cable was reseated and the limb leads replaced and the issue was resolved.The bwi field representative called back as the issue returned.The body surface (bs) cable was replaced with no resolution along with the ecg patches.The ecg in port was examined and it looked fine with no bent pins.No red lights on the back of the patient interface unit (piu).The ecg out cable was replaced with no resolution.The intracardiac (ic) out was removed and the piu was turned off and the ep recorder regained signals.The piu was powered on and the iceg and bs cable were removed.There was an error 1201 with bs cable plugged in.Limb lead disconnected.Additional information was received stating the procedure was cancelled.The patient was under general anesthesia for approximately 2 hours.There was no transseptal puncture.The dampened signals were on the body surface ecg's.Intracardiac signals were not present as they did not have catheters in the patient yet.The physician did have ecg signals on the recording system to monitor the patient but they were very low amplitude.The lab also had the patient monitored on an external defibrillator and anesthesia monitor.However, the physician canceled the procedure as there was not enough adequate ecg's to monitor the patient to perform the ablation.The venous sheaths were removed after approximately an hour of active trouble shooting.There were signals to monitor the patient's heart rhythm.However, we are reporting this event due to the risk assessed by the physician that he could no longer continue the procedure as there were not enough adequate ecg's to perform the ablation.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.It was reported that the 12 leads have low amplitude on the carto 3 system and ep recorder.The body surface (bs) cable was replaced with no resolution along with the ecg patches.The ecg in port was examined and it looked fine with no bent pins.No red lights on the back of the patient interface unit (piu).The intracardiac (ic) out was removed and the piu was turned off and the ep recorder regained signals.The piu was powered on and the iceg and bs cable were removed.There was an error 1201 (ecg limb lead disconnection) with the bs cable plugged in.The bwi field service engineer (fse) visited the account regarding the issue.During troubleshooting, the fse inspected the ecg port on the piu and noticed that some of the pins were deformed and damaged and that the bs ecg cable appeared damaged as well.The fse replaced the back plane card and bs ecg cable.The fse then performed atp tests on the system.All tests passed.The fse followed up with the bwi field representative and confirmed that the issue was resolved.The system is ready for use.The faulty bs ecg cable was replaced with a new one.The faulty back plane card was sent to device manufacturer for investigation.The customer complaint was confirmed.The ecg connector was found damaged and was replaced.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 20667 17; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4922501
• MDR Text Key: 22502359
• Report Number: 3008203003-2015-00056
• 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
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1