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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: only a celect filter was returned and investigation revealed two of the primary legs were squeezed, thus resulting in a smaller diagonal distance. Two secondary filter legs were intertwined, but when uncrossed all secondary legs look fine and with no damages. The exact reason why the filter "legs failed to open and tilt" cannot be determined. However, the filter legs may have been somehow obstructed from fully expanding due to e. G. Ivc anatomical conditions, clots or if not placed in ivc. Also, the root cause for the intertwined filter legs cannot be determined, but the filter may have been twisted during the loading of the filter into the sheath or possibly while advancing the filter out of the sheath resulting in the secondary filter legs becoming intertwined. During the manufacturing/qc processes the spring effect of filter is 100 % controlled, as they are all deployed after advancement through a sheath. Under normal conditions, ivc< 30 mm, the radial force of filter will make filter legs attach to ivc. During manufacturing processes the distances between primary filter legs are verified. Also, after advancement through a testing sheath the spring effect of every filter is verified. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "had a young male in his (b)(6), trauma patient. First shot of the ivc was clear so they went to place the celect filter, femoral approach. When they hit the button to release the primary legs, they did not open. The filter was tilted in the ivc with the legs closed. The filter was snared and removed. Placed another manufacturers filter to complete the procedure. " patient outcome: no adverse effects.
 
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Brand NameUNKNOWN
Type of DeviceDTK 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 Key6338279
MDR Text Key245854625
Report Number3002808486-2017-00544
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/31/2017
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Yes
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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