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

Model Number M-4800-01

Device Problems No Display/Image (1183); Noise, Audible (3273)

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

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field service engineer (fse) was not able to reproduce reported issue but due to its intermittent nature the fse replaced the backplane card in piu and performed atp and preventative maintenance.All test passed.The system is ready for use.Suspected backplane card was sent to device manufacturer for investigation.The customer complaint was not confirmed.The eeprom error was not reproduced.The map port was tested and works properly.The noise issue was not reproduced either.All signals visible clean.The card passed all required tests and found operational.The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

Event Description

It was reported that a patient underwent a supraventricular tachycardia procedure with a carto 3 system and a noise issue occurred.When the 4mm navistar catheter was connected to the carto 3 system, an eeprom error was seen.The electrocardiogram (ecg) signals became noisy and the catheter would not display.The user tried a new cable and catheter without resolution.The user then reseated the catheter within the map port of the patient interface unit and the issue resolved.The noise was noticed on all ecg channels including intracardiac and body service as well as the anesthesia monitor, carto 3 system and the recording system.There was no ecg signal available for the physician to monitor the patient's heart rhythm.Therefore this event has been assessed as mdr reportable because lack of monitoring of cardiac rhythm while devices are intra-cardiac may lead to potential patient injury.The other issues experienced during the case, eeprom error and catheter visualization issue are not mdr reportable because the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.The awareness date for this record is march 28, 2016 because additional information was received that there was no ecg signal available to monitor the patient's heart rhythm.

• 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: 5592096
• MDR Text Key: 44338454
• Report Number: 3008203003-2016-00013
• 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
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1