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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 Bent (1059); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Thrombosis (2100); No Information (3190)
Event Date 08/22/2013
Event Type  Injury  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Corrected data based on new information received: adverse event to product problem, serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 10/17/2017 as follows: patient received an implant on (b)(6) 2013 via the left internal jugular vein due to deep vein thrombosis. Patient experiences device tilt, filter leg bent, embedment and that the device is unable to be retrieved. Patient is alleging recurrent dvt/pe due to the device. Retrieval was attempted on (b)(6) 2013.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Corrected data based on new information received: product problem to adverse event and product problem, to serious injury, malfunction to serious injury. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'device tilt, filter leg bent, embedment, unable to be retrieved, recurrent dvt/pe'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time. 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.
 
Manufacturer Narrative
Exemption number (b)(4). William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4). Catalog# is unknown but referred to as cook celect filter. (b)(4). Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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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
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6943328
MDR Text Key250282967
Report Number3002808486-2017-01955
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 consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/21/2017
Event Location No Information
Date Manufacturer Received11/08/2017
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

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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