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

Model Number M-4800-01

Device Problem Positioning Problem (3009)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the customer experienced a map shift approximately 4 cm without any error on the carto system.The map shift was noticed by fluoro when physician was on posterior wall by fluoro, ice and carto map had ablator on septum.The case was completed with the map shift without any patient consequence.Per carto 3 ifu map shift without indication may occur if back patches move along z- axis.Before applying rf energy, visually verify correctness of the tip position of the mapping catheter in relation to the visualized map.Use your common clinical practice, such as fluoroscopy or inspection of ic signals, to verify the location of the catheters throughout the procedure.Failure to do so might result in incorrect placement of the catheter.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Refer to evaluation summary: (b)(4).It was reported that during an atrial fibrillation (afib) procedure, the customer experienced a map shift approximately 4 cm without any error on the carto system.The map shift was noticed by fluoro when physician was on posterior wall by fluoro, ice and carto map had ablator on septum.The case was completed with the map shift without any patient consequence.The piu was replaced and the system passed all tests.The piu was sent to manufacturer (htc) for return merchandize authorization investigation process.The customer complaint regarding map shift issue was not confirmed since the map shift was not duplicated.During investigation, it was found, the piu found failed as well as acl card.However the piu passed aquarium tests with a few types of catheters, service jig utility tests (sju) was done.The piu checked and build current to position mapping (cpm) with lasso and map.The piu passed isolation test.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed and no anomalies were noted in manufacturing or servicing of this equipment.In addition, a corrective action has been opened to address and resolve this disconnection in the acl tx card issue.

• 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: 4204396
• MDR Text Key: 4979084
• Report Number: 3008203003-2014-00070
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 10/01/2014

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: 09/29/2014
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1