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

Model Number M-4800-01

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a carto 3 system and a map shift ¿ no error message issue occurred.There was a map shift on rao view during the procedure.The issue was resolved by moving the fluoro tube.The procedure was completed without patient consequence.Upon request, additional information was provided on the event on (b)(4) 2014.The shift was noticed during the mapping portion of the procedure.The issue occurred with the movement of the fluoro tube.A stable lao his position was confirmed and when the tube was rotated to rao, the catheter shifted.Lao position corrected the shift.The sid values for this particular fluoro system are very strict.The shift was noticeable at about 2cm.There were no errors associated with the catheter shift.There was no shift during rf delivery.We recognized the shift and positioned the fluoro accordingly.This event was originally considered non-reportable, however, bwi became aware of no error message with this type of map shift on (b)(4) 2014 and have reassessed the event as reportable.

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).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a carto 3 system and a map shift ¿ no error message issue occurred.There was a map shift on rao view during the procedure.The issue was resolved by moving the fluoro tube.The procedure was completed without patient consequence.The shift was noticed during the mapping portion of the procedure.The issue occurred with the movement of the fluoro tube.A stable lao his position was confirmed and when the tube was rotated to rao, the catheter shifted.Lao position corrected the shift.The sid values for this particular fluoro system are very strict.The shift was noticeable at about 2cm.There were no errors associated with the catheter shift.There was no shift during rf delivery.They recognized the shift and positioned the fluoro accordingly.The reported issue was related to the user error and was resolved by fluoro tube repositioning.The bwi field service engineer completed all system acceptance tests.The system is ready for use.According to carto 3 instructions for use, fluoroscopy devices that are too close to the patient might affect location accuracy and, as a result, catheter visualization.The device history record (dhr) 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: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: 4100409
• MDR Text Key: 20270512
• Report Number: 3008203003-2014-00061
• 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: 08/19/2014

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: 08/15/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1