MAUDE Adverse Event Report: COOK MEDICAL INC COOK CELECT VENA CAVA FILTER

Model Number REF# IGTCFS-65-1-FEM-CELECT

Device Problem Malfunction (2409)

Patient Problem No Code Available (3191)

Event Date 09/30/2013

Event Type  Malfunction  

Event Description

Pt was getting an ivc filter placed by trauma. Upon deployment of the filter, one of the legs bent. Md progress notes states he will consider having the pt will need to go to ir to have defective filter removed and a new filter placed. The filter is a cook celect vena cava filter ref igtcfs-65-1-fem celect. Order number (b)(4).

• Brand Name: COOK CELECT VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): COOK MEDICAL INC; bloomington
• MDR Report Key: 3546130
• MDR Text Key: 4125234
• Report Number: 3546130
• Device Sequence Number: 1
• Product Code: DTK

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/30/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/07/2013
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: REF# IGTCFS-65-1-FEM-CELECT
• Device Catalogue Number: G52914
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2013
• Event Location: Hospital
• Date Report TO Manufacturer: 09/30/2013
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 11/07/2013 Patient Sequence Number: 1