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

Model Number M-4800-01

Device Problem Radio Signal Problem (1511)

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

Event Date 03/31/2013

Event Type  malfunction  

Event Description

It was reported that during the atrial flutter right (r-afl) procedure, while pacing from 20b, they lost all body surface (bs) and intracardiac (ic) egms on both the carto 3 system and on the recording system.It was also reported that during the same procedure, they lost all bs and ic egms on both the carto 3 system and on the recording system intermittently when they were pacing from ref/deca and only during ablation.There was no patient injury reported.Upon request, additional information was provided on the event.It was planned pacing.The signal loss was mainly on the 12 leads.The signal loss was on both the carto 3 system and the recording system at the same time.The physician did not have any signals available to monitor the heart rhythm.The signal loss occurred during ablation and pacing.The procedure was able to be completed.Per the event stating the loss of all signals ic and bs on both the carto 3 system and the recording system at the same time is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during the atrial flutter right (r-afl) procedure, while pacing from 20b, they lost all body surface (bs) and intracardiac (ic) egms on both the carto 3 system and on the recording system.It was also reported that during the same procedure, they lost all bs and ic egms on both the carto 3 system and on the recording system intermittently when they were pacing from ref/deca and only during ablation.There was no patient injury reported.The bwi field service engineer first performed the ecg modular atp and the pacing test failed.He then reseated the ecg cards and tested it again which resulted in the test passing.Reseating the ecg cards resolved the issue.The system is ready for use.An additional oem manufacturer action device history record (dhr) review was performed.No anomalies were noted in manufacturing or service.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3778666
• MDR Text Key: 15806400
• Report Number: 3008203003-2014-00033
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• 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: 03/31/2014

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: 03/31/2014
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1