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

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 06/17/2015

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a carto 3 system and a map shift with no error message occurred.The fast anatomical mapping geometry of the ultrasound catheter was off by 3 to 4 cm on the carto 3 system.The issue was resolved by replacing the soundstar eco 10f catheter.The case was completed with no patient consequence.Upon request additional information was received on the event.The map shift was discovered when the aortic valve image did not meet up with where the aortic valve should be.This event is indicative of a reportable event because a map shift with no error message poses a potential risk to patient.

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a carto 3 system and a map shift with no error message occurred.Field service engineer followed up on the issue with bwi representative and confirmed that the replacement soundstar eco 10f catheter resolved the issue.System is operational.The history of customer complaints associated with this carto 3 system was reviewed.There were not any additional reported complaints that may be related to the reported issue.Device history record 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: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4910171
• MDR Text Key: 22401853
• Report Number: 3008203003-2015-00053
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• 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
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1