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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI-CELECT
Device Problems Failure to Capture (1081); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Lot#: unknown as information was not provided. Catalog#: igtcfs-65-uni-celect expiration date: unknown as lot# is unknown. Similar to device under 510(k) k073374. (b)(4). Summary of investigational findings: available images from deployment confirm that the filter placement looked normal. But the images also confirm that the filter had tilted 14 days after placement. However, filter configuration is normal. It was not possible to cover the filter completely with the inner and outer sheath of the gtrs-200-rb, since the filter legs were attached to the vena cava wall. Imaging from retrieval attempt show that the filter collapsed partly. Most likely the physician twisted the gtrs-200-rb during the retrieval attempt and thereby the filter legs got entangled and stayed collapsed when gtrs-200-rb was removed. Tilt is considered as a well known risk, which is described in the scientific literature. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: ivc filter was placed on (b)(6) 2011. Ct scan on (b)(6) 2011 showed ivc filter tilted 30 degrees from insertion date. Retrieval of the ivc filter was attempted on (b)(6) 2011 without success. The filter legs had imbedded in the wall and would not release when snared and pulled on with gtrs-200-rb. Patient outcome: the celect ivc filter was left in the ivc as it wasn't retrievable. No adverse effects to the patient were reported.

 
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Brand NameCOOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5895667
MDR Text Key52727481
Report Number3002808486-2016-00912
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-UNI-CELECT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/23/2016 Patient Sequence Number: 1
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