MAUDE Adverse Event Report: ST. JUDE INC LIVEWIRE STEERABLE EP CATHETER; CATHETER, GUIDEWIRE, EP

Catalog Number 401904

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2015

Event Type  malfunction  

Event Description

Tip of catheter bent to the point of loss of maneuverability.Unable to use for case.

• Brand Name: LIVEWIRE STEERABLE EP CATHETER
• Type of Device: CATHETER, GUIDEWIRE, EP
• Manufacturer (Section D): ST. JUDE INC; 14901 deveau pl.; minnetonka, MN 55345
• MDR Report Key: 5453500
• MDR Text Key: 38770070
• Report Number: 5453500
• Device Sequence Number: 0
• Product Code: DRF
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 401904
• Device Lot Number: 5080741
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR