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

Model Number M-4800-01

Device Problems Image Display Error/Artifact (1304); Misconnection (1399)

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

Event Date 10/29/2015

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, (b)(6), male, underwent an atrial fibrillation procedure with a carto 3 system and a visitag issue occurred.In the study, there was only one map of the left atrium and it was transparent.Several ablations were done and the visitags would appear but then disappear after a few second or sometimes longer.Then the system started showing the visitags but only some of the time.Only about half or one third of the tags appeared and the rest were lost.Approximately halfway through the procedure it was discovered that the i/o cable was not connected properly into carto.Therefore the fiber cable was reversed and properly connected.The system then gave some visitags; however, it appeared as though other visitags were disappearing after some time for no apparent reason.There was no delay to the procedure.The procedure was completed with no patient consequence.Upon request additional information was received on the event.There were no unwanted ablations performed.The physician only ablated in areas where he still had a signal.The missing visitag points were never retrieved.This event has been assessed as indicative of a mdr reportable event because loss of ablation data could mislead a physician and poses a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient, (b)(6), male, underwent an atrial fibrillation procedure with a carto 3 system and a visitag issue occurred as the visitags would appear but then disappear.This is a user error issue.Field service engineer reported that after i/o cable was re-connected, the issue has been corrected.System is fully functional and ready for clinical use.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 ; 9497893837
• MDR Report Key: 5232779
• MDR Text Key: 31792329
• Report Number: 3008203003-2015-00091
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/29/2015

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: 10/29/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 95