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); Issue With Displayed Error Message (2967); Unintended Movement (3026)

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

Event Date 02/02/2017

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 a right sided atrial flutter procedure with a carto® 3 system and a map shift without error message occurred.Error 8 ¿stimulation routing is disabled¿ displayed on the carto® 3 system.The pacing leads were connected to the carto® 3 patient interface unit (piu) primary pacing port.A bloom stimulator was used during the procedure.The pacing was for planned pacing and no pacing was delivered.Everything was blacked out on the carto® 3 including no mapping or fast anatomical mapping available.All catheters and cables were removed and the piu was rebooted.The error was resolved after reboot and after reconnecting all catheters, the error did not return and the case continued.Then, while mapping, there was a map shift with no error message or patient movement.The map shift was confirmed by the physician using fluoroscopy and looking at the map created with carto® 3.The measured map shift distance was 16.9mm; the carto was used to measure the difference.There was no prior cardioversion and the patient was fully sedated prior to procedure.The pacing error is not mdr reportable because the potential that this issue could cause or contribute to a death or serious deterioration in the patient¿s state of health is remote.The map shift is mdr reportable because map shifts could potentially be caused by system malfunction, and there is a potential risk to patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a right sided atrial flutter procedure with a carto® 3 system and a map shift without error message occurred and error 8 ¿stimulation routing is disabled¿ displayed on the carto® 3 system.Error 8 was resolved by removing all catheters from patient interface unit (piu) and performing a piu reboot.When connecting all catheters the error did not return and the case was completed.The field service engineer (fse) cannot determine the cause of the error.The error has not returned.It was also reported that while mapping there was a map shift and there was no patient movement.It was clarified by the bwi representative that the issue was seen after re-initializing and restarting the piu after they had the error 8.Fse reported that the map shift was not reproduced in following case.The 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 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: 6361267
• MDR Text Key: 68969001
• Report Number: 3008203003-2017-00010
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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: 02/02/2017
• 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