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); Failure to Align (2522); Unintended Movement (3026)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During the procedure, the physician stated that the catheter was freezing intermittently.Cs catheter on carto system did not align on what was observed on univu image.No system warning was displayed for map shift.Troubleshooting was performed until a new map was created, overlapped with initial map and observed the difference alignment.The procedure was continued with no patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event was determined to be reportable as no error message was displayed for the map shift and could potentially be a risk for the patient.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.Manufacturer's reference # (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During the procedure, the physician stated that the catheter was freezing intermittently.Cs catheter on carto system did not align on what was observed on univu image.No system warning was displayed for map shift.Troubleshooting was performed until a new map was created, overlapped with initial map and observed the difference alignment.The procedure was continued with no patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event was determined to be reportable as no error message was displayed for the map shift and could potentially be a risk for the patient.The investigational analysis has been completed.It was reported that the catheter freezing, intermittently during case.The issue was investigated in device manufacturer (htc) and identified as hard disk configuration - 4k sectors, workstation (ws) was replaced, issue was resolved.Issue related to bug #34150 for the wavefront annotation of v signal, cs catheter on carto did not align with cs shadow on univu image, woi reset, cont acquisition disabled, resp filter for visitag not able to be selected before accuresp training conducted, baseline points disappearing within window.It was investigated that the provided data is lack with information, based on the available information the root cause of these failures cannot be determined.As for the physician certain of map shift, however, no system warning.New map created when overlaid with initial map clear difference in alignment observed.This issue was not duplicated.Suspected reason: metal interference and wrong clinical information.Investigation of the study not allowed by the regulatory department due to the data restriction.The provided data is lack with information, based on the available information the root cause of the failure cannot be determined.A device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore no capa activity is required.The customer complaint was confirmed.

• 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4165434
• MDR Text Key: 4788214
• Report Number: 3008203003-2014-00065
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

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: 09/22/2014
• Initial Date FDA Received: 10/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1