MAUDE Adverse Event Report: COOK MEDICAL CELECT IVC FILTER

Catalog Number IGTCFS-6S-FEM

Device Problem Fracture (1260)

Patient Problem Embolism (1829)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Fractured and embolized cook celect ivc filter struts.Dates of use: (b)(6) 2011, (b)(6) 2016.Diagnosis or reason for use: dvt s/p gunshot (b)(6) 2011.Three fractured ivc filter legs 2 embolized, one to right atrium, one to right lower lobe lung.

• Brand Name: CELECT IVC FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 6199149
• MDR Text Key: 63229242
• Report Number: MW5066862
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-6S-FEM
• Device Lot Number: E2649498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INITIAL REPLACEMENT OF FILTER
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR