MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. EZ STEER NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number BN7TCDF4L

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Event Description

Noise was seen on proximal electrodes (poles 3, 4) and did not go away.The patient was not harmed.

• Brand Name: EZ STEER NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 7486383
• MDR Text Key: 107342947
• Report Number: 7486383
• Device Sequence Number: 1
• Product Code: DRF
• 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: Other
• Type of Report: Initial
• Report Date: 04/27/2018

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: Unknown
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 3002523M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR