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

Model Number M-4800-01

Device Problems Device Sensing Problem (2917); Noise, Audible (3273)

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

Event Date 12/17/2013

Event Type  malfunction  

Event Description

It was reported that after they did a cardioversion at the end of the atrial fibrillation (afib) procedure, they began getting pulse of interference on all body surface and intracardiac channels both on the carto 3 system and the cardiolab recording system.The issue was resolved when the catheter was disconnected from the 20 pole b but the issue re-appeared when the catheter was reconnected.Upon request, additional information was provided on the event.The signal noise pulses prevented legible interpretation of all signals.The physician was not able to interpret the bs and all ic recordings.The cardioversion was performed after the ablation procedure as they did not terminate the arrhythmia with the ablation.The cardioversion was not an emergency.The severity of the noise on all the channels on both the carto 3 system and the cardiolab 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).

• 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: 3563078
• MDR Text Key: 4210670
• Report Number: 3008203003-2014-00002
• 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
• Report Date: 12/17/2013

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
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1