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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problems Malposition of Device (2616); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under pma/510(k) # k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: due to the risk of pulmonary thromboembolism, of the pathology, and previous to surgery a celect filter was implanted, with small angulation (less than 15 %). In a control one of the secondary legs was bended in a big angle, predicting big risk on a future removal. Explant attempt: (b)(6) 2020. The situation is that they first tried the retrieval and discovered the abnormal placement of the filter, so it was decided to postpone the removal in order to study and decide the best approach. Patient outcome: the filter is still in place. According to the initial reporter the filter is working for the moment but risky future removal procedure prediction.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key9669772
MDR Text Key195561010
Report Number3002808486-2020-00134
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/05/2020
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-PT
Device LOT NumberE3876715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/17/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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