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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT
Device Problems Bent (1059); Failure to Capture (1081)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Lot#: unknown as information was not provided. Catalog#: igtcfs-65-2-uni-celect. Expiration date: unknown as lot# is unknown. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no product or images provided. Very limited information of the retrieval attempt. Therefore the exact reason for the retrieval difficulties and why "the filter was bent during attempt on getting the filter out" cannot be determined. It is unknown which device was used for retrieval. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: one of the legs of the filter was bent during the attempt of getting the filter out. Patient outcome: the patient did require any additional procedures due to this occurrence. Need to plan a second attempt to get the filter out. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
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 Key5895665
MDR Text Key52731663
Report Number3002808486-2016-00913
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeNL
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 03/21/2014
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-65-2-UNI-CELECT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
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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