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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-1-fem-celect-pt. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "the physician went in via femoral access, unsheathed and released the filter. Upon filter release 2 of the primary legs were twisted/criss-crossed once. The physician spent the next 45 minutes with wires and catheters to untwist the filter which was successful with no harm to the patient. " patient outcome: the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-1-fem-celect-pt. (b)(4). Summary of investigational findings: according to the description of event, two of the primary legs were twisted upon deployment - the physician did successfully un-twist the filter using "wires and catheters". It is noted that no harm was done to the patient. Based on the limited information provided it would be inappropriate to speculate at what may or may not have occurred and the root cause for the reported twist of filter legs upon deployment cannot be determined. Reference is made to ifu, filter placement, warning: do not rotate the released filter inside the vena cava. Doing so may compromise the performance of the filter. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: "the physician went in via femoral access, unsheathed and released the filter. Upon filter release 2 of the primary legs were twisted/criss-crossed once. The physician spent the next 45 minutes with wires and catheters to untwist the filter which was successful with no harm to the patient. " patient outcome: the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN FEMORAL 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 Key6344657
MDR Text Key67946783
Report Number3002808486-2017-00583
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/01/2017
Event Location No Information
Date Manufacturer Received02/01/2017
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

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