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

Model Number M-4800-01

Device Problem Invalid Sensing (2293)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/10/2017

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.There was an electrocardiogram (ecg) signal loss on the carto 3 system and the recording system when the smart touch catheter was plugged into the carto patient interface unit during the procedure.They rebooted the system, unplugged and reconnected all cables.However, the issue continued.They also replaced three cables and two catheters.However, the issue continued.The procedure was cancelled as a result of this issue.There were no patient consequences.Additional information was received stating that they did have ecg signals available to monitor the patient¿s heart rhythm.The patient was under general anesthesia for a total of 2.5 hours.A transseptal puncture was performed prior to the case cancellation.The patient required extended hospitalization as a result of the procedure cancellation.The physicians kept the patient at the hospital as the procedure was postponed until (b)(6) 2017.The signal loss issue was assessed as not reportable as the patient's heart rhythm was still visible to the operator when signal loss occurred.Therefore, the risk to the patient was low.The procedure cancellation was assessed as reportable malfunction as the cancellation required the patient to receive extra care.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.There was an electrocardiogram (ecg) signal loss on the carto 3 system and the recording system when the smart touch catheter was plugged into the carto patient interface unit during the procedure.They rebooted the system, unplugged and reconnected all cables.However, the issue continued.They also replaced three cables and two catheters.However, the issue continued.The procedure was cancelled as a result of this issue.There were no patient consequences.Additional information was received stating that they did have ecg signals available to monitor the patient¿s heart rhythm.The patient was under general anesthesia for a total of 2.5 hours.A transseptal puncture was performed prior to the case cancellation.The patient required extended hospitalization as a result of the procedure cancellation.The physicians kept the patient at the hospital as the procedure was postponed until (b)(6) 2017.The biosense webster, inc.Field service engineer visited the account and resolved the issue by replacement of the backplane card.Preventive maintenance was successfully performed on the system.System is ready for clinical use.Replaced backplane card was sent to the device manufacturer for investigation.The customer complaint was confirmed.The card failed: the pins in the map connector were found damaged and caused the issue.The damaged connector 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6284915
• MDR Text Key: 66252211
• Report Number: 3008203003-2017-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• 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: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1