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 Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

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 procedure with a carto 3 system.It was reported that there was pacing indicated on the ablation channel during radio frequency energy delivery with use of the carto 3 system during the procedure.There were no patient consequences.Pacing and ablating should not be allowed simultaneously from the same channel on the carto 3 system.This event was assessed as a reportable malfunction as there is a risk of disorganization of the electrical signal.This could mislead the physician.Therefore, the potential that this issue could cause or contribute to a death, serious injury, or other significant adverse event was possible.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a carto 3 system.It was reported that there was pacing indicated on the ablation channel during radio frequency energy delivery with use of the carto 3 system during the procedure.There were no patient consequences.It was reported that the ecg card was replaced.The system was tested after card replacement.Issue resolved and system is operational.The faulty ecg card was sent to the device manufacturer for investigation.Per the device manufacturer, the customer complaint was confirmed.One of the opto-couplers was found damaged and it caused the issue.The defective element was replaced and the card returned to correct functionality.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.An internal corrective action has been opened to investigate opto switches and tvs failures.

• 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: 6205472
• MDR Text Key: 63704704
• Report Number: 3008203003-2016-00048
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• 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