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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. CELECT IVC FILTER

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COOK, INC. CELECT IVC FILTER Back to Search Results
Device Problems Material Fragmentation (1261); Tip (3123)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Bone Fracture(s) (1870)
Event Date 11/14/2018
Event Type  Injury  
Event Description

Pt with celect ivcf, placed in 2009, failed attempt at retrieval 3 months later, found to be multiply fractured with 3 legs broken off-one deeply embedded in spine, one in a left hepatic vein, and one near the right costophrenic angle possibly in the liver and possibly outside the liver, but not clearly intravascular. One leg still attached deeply penetrated the aorta. Tip was embedded. Filter was removed with forceps, and the "hepatic vein fragment was removed. The spinal fragment was retained as well as the costophrenic angle one.

 
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Brand NameCELECT
Type of DeviceIVC FILTER
Manufacturer (Section D)
COOK, INC.
bloomington IN
MDR Report Key8084935
MDR Text Key128022215
Report NumberMW5081439
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 11/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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: 11/16/2018 Patient Sequence Number: 1
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