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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 Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510k#: similar device under 510(k)/pma k121629. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: the strut of the ivc filter was found kinked. The user found out it was kinked when they were opening the packaging. The filter was discarded and a new set of g34504 was opened. Patient outcome: unknown.
 
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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 Key8330205
MDR Text Key139077190
Report Number3002808486-2019-00197
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeHK
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 06/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2021
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device Lot NumberE3689746
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/21/2019
Device Age11 MO
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2018
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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