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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 Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/31/2017
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: while putting the device through the femoral sheath, the device stopped advancing.The physician was uncomfortable with advancing further and pulled back, which deformed the filter.The device was removed from the patient and another of the same device was used to successfully complete the procedure.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description only.No product was returned to assist the investigation and without the actual complaint device, it would be inappropriate to speculate at what may or may not have caused the difficulties in advancing the filter through the sheath.However, filters advanced via femoral approach are attached to the femoral introducer by the primary filter legs only - the secondary filter legs are expanded and will be damaged if pulled back through the hub of the sheath.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key6903212
MDR Text Key89426274
Report Number3002808486-2017-01904
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date09/05/2017
Date Manufacturer Received12/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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