MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. EZ STEER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number BN7TCDF4L

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 07/27/2015

Event Type  malfunction  

Event Description

Ez steer biosense webster bidirectional catheter was not registering temperature appropriately.Physician removed the device and used another catheter that sensed correctly.

• Brand Name: EZ STEER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 3333 diamond canyon road; diamond bar CA 91765
• MDR Report Key: 5013196
• MDR Text Key: 23401464
• Report Number: 5013196
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/30/2018
• Device Model Number: BN7TCDF4L
• Device Lot Number: 17233111M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1