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

Model Number M-4800-01

Device Problems Unable to Obtain Readings (1516); Noise, Audible (3273)

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

Event Date 12/19/2013

Event Type  malfunction  

Event Description

It was reported that in the middle of the atrial flutter (afl) procedure, all the electrograms on both the carto 3 system and the recording system became very noisy and unreadable.The caller was instructed to check the limb leads of the body surface.The caller was then instructed to unplug all catheters from the front of the patient interface unit (piu).The noise was gone.The caller was then instructed to reseat all the catheters one by one.All the noise was resolved, but the ref/deca port was "sticky" and the cable did not seat easily.There was no patient injury reported in this procedure.The severity of the noise on all the channels 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.Manufacturer's ref.No: (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: 3562851
• MDR Text Key: 20006277
• Report Number: 3008203003-2014-00001
• 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: 12/19/2013

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: 12/19/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1