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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a carto 3 system.A map shift with no error message was reported with the use of the carto 3 system during the procedure.There was no movement of the patient or patches and there was no metal interference.It was stated that the catheter seemed to have dropped into a pouch.No troubleshooting could be performed.The procedure was completed with no patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This map shift with no error message was assessed as a reportable malfunction as such map shifts could potentially be caused by a system malfunction and there would be a potential risk to the patient.

Manufacturer Narrative

Manufacturer's ref.(b)(4), it was reported that a patient underwent an atrial flutter (afl) procedure with a carto 3 system.A map shift with no error message was reported with the use of the carto 3 system during the procedure.There was no movement of the patient or patches and there was no metal interference.It was stated that the catheter seemed to have dropped into a pouch.No troubleshooting could be performed.The procedure was completed with no patient consequences.The biosense webster field service engineer arrived on site for troubleshooting and repair.There was noticeable damage to the location pad cable.Exposed wires were found.The biosense webster field service engineer was unable to initialize with the current location pad cable.The biosense webster field service engineer confirmed that the reported issue was due to the damaged location pad cable.Upon repair, the biosense webster field service engineer disposed of the location pad cable, as there was clear visible damage that the cable was torn away from base and this was the root of the reported issue.Full atp/preventative maintenance was successfully completed.Issue is resolved.System is ready for use.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: 6211010
• MDR Text Key: 63812433
• Report Number: 3008203003-2016-00049
• 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,Followup
• Report Date: 11/29/2016

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: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• 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