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

Model Number M-4800-01

Device Problems Device Inoperable (1663); No Pacing (3268)

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

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).The field service engineer was able to reproduce the issue.The pins on the ecg card were not properly secured to the piu backplane card.Re-seating the ecg cards resolved the issue.Annual preventative maintenance was also done.All tests passed.System is up and ready for use.The device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and the system was unable to pace through the main routing port during emergency pacing.Changing out the pacing cable did not resolve the issue.Connecting to the emergency pace ports or bypassing the patient interface unit (piu) of the carto 3 system did allow for pacing.There was no ablation performed, only pacing of the coronary sinus catheter through the piu and micropace stimulator.No unwanted pacing was delivered at any time during the procedure.The procedure was completed with no patient consequence.This event is mdr reportable.Even though catheters are not intended for emergency pacing, the physician may choose to use the catheter to pace the heart when emergency pacing is needed.There is risk to the patient if the catheter is not able to pace during an emergency.

• 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: 6807047
• MDR Text Key: 83313439
• Report Number: 3008203003-2017-00031
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• 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
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1