MAUDE Adverse Event Report: BIOSENSE WEBSTER BIOSENSE; CARTO 3 SYSTEM

Model Number CARTO 3 SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/09/2016

Event Type  malfunction  

Event Description

Patient in for ep procedure and biosense carto 3 system malfunctioned.It would not recognize the magnet patches causing the procedure to be canceled after the patient had been given versed.

• Brand Name: BIOSENSE
• Type of Device: CARTO 3 SYSTEM
• Manufacturer (Section D): BIOSENSE WEBSTER; diamond bar CA 91765
• MDR Report Key: 6127370
• MDR Text Key: 60993055
• Report Number: MW5066296
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2016

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: CARTO 3 SYSTEM
• Device Catalogue Number: SW VERSION 3.4.5.68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR