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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK CELECT IVC FILTER

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COOK CELECT IVC FILTER Back to Search Results
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 12/20/2017
Event Type  Injury  
Event Description
Celect filter placed in 2014 found to be fractured and deeply embedded in vertebral body, no prior attempt at removal. Pt has severe chronic back pain, narcotic dependent, almost certainly as a result of this filter penetration. Removed filter with forceps (tip-embedded). Also penetrated anteriorly with leg in duodenum, pt has had gi bleeding possibly related to filter penetration. Fragment which is extravascular left behind.
 
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Brand NameCELECT
Type of DeviceIVC FILTER
Manufacturer (Section D)
COOK
bloomington IN
MDR Report Key7142109
MDR Text Key95755994
Report NumberMW5074178
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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