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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC. COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC. COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM-CELECT-PERM
Device Problems Material puncture; Implant, removal of
Event Date 06/03/2008
Event Type  Injury  
Manufacturer Narrative

Event evaluation - still under investigation.

 
Event Description

A female had celect vena cava filter placement in 2008 via right femoral vein prior to bariatric surgery scheduled on the next day. Pt presented to the er four weeks later with complaints of right side back pain. Ct scan of abdomen showed a large right retroperitoneal hematoma displacing the right kidney anteriorly. Hematoma extends into the pelvis. There appears to be two or three of the primary strut legs puncturing the ivc. The pt was referred back to the cardiologist for filter retrieval. The physician retrieved the filter via the right jugular approach without complications. The ivc was patent with no overt leak. The filter was discarded and not available for examination. The filter was intact and not damaged by visual inspection according to the physician. The lot number of the filter is not available as it was not annotated in the pt's records. The pt did receive two units of blood during this hospitalization as her hgb dropped to 8. 5 on the following month from the pre-surgical hgb of 14. 0 on original date. Labs repeated on the following month, with hbg 11. 0 and hct 35. 4.

 
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Brand NameCOOK CELECT FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section F)
COOK INC.
bloomington IN 47404
Manufacturer (Section D)
COOK INC.
bloomington IN 47404
Manufacturer Contact
anita kvistgaard, manager
sandet 6, dk-4632
bjaeverskov  
DENMARK   4632
455 686 8686
Device Event Key1087639
MDR Report Key1104047
Event Key1060418
Report Number3002808486-2008-00012
Device Sequence Number1
Product CodeDTK
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/08/2008,07/11/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/22/2008
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2008
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/16/2008
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/08/2008 Patient Sequence Number: 1
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