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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 Split (2537); Difficult to Advance (2920)
Patient Problem No Patient Involvement (2645)
Event Date 09/29/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Igtcfs-65-2-uni-celect. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: the celect filter was returned together with introducer and protection sheath. Approximately 39mm of the distal tip of the protection sheath was found split as reported. A 54mm from distal tip the protection sheath exhibited a minor kink and since the kink was situated in the area where the grasping hook caught the filter hook, the filter must have been correctly placed/withdrawn into the sheath. Assuming the filter legs somehow caused the protection sheath to split, several attempts were made to duplicate the incident, but with no success. The sheath was not returned and therefore it is difficult to comment on "resistance during introducing," and consequently the exact reason for this type of damage cannot be determined. There is found no evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: the filter delivery sheath split. Physician attached the celect filter to the jugular set and advanced the jugular sheath over it, he noticed that the filter 'feet' were visible and protruding slightly at the end of the sheath. He then attempted to insert the filter into the check flow valve of the jugular sheath, he encountered more resistance than he has usually experienced, eventually the filter entered the valve but was not moving freely so he removed it. When removed it , the sheath was split and the filter exposed. He then opened another igtcfs-65-2-uni-celect and proceeded with the filter placement easily. He used the original jugular sheath with a new filter and introducer. Patient outcome: no additional procedures needed to be performed. No adverse effects on the patient were reported.

 
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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 Key5905942
MDR Text Key53279655
Report Number3002808486-2016-00921
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 10/06/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/28/2011
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: 08/26/2016 Patient Sequence Number: 1
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