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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 Problem Occlusion Within Device (1423)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Unknown as lot # is unknown. Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014. " "on or about (b)(6) 2015, [pt] presented for removal of ivc filter. At that time, removal of the retrieval ivc filter was not accomplished secondary to complete total occlusion of the inferior vena cava below the filter. " patient outcome: it is alleged that "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] has suffered emotional trauma, harm and injuries that will continue into the future. [pt] has lost his ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills, both past and future, related to care because of the cook ivc filters¿ defects. ".
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as a cook celect filter. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Summary of investigational findings: investigation is solely based on description of event. No product was returned and no imaging was provided. According to the description of event, the filter could not be removed, due to "total occlusion of the inferior vena cava below the filter. " given the limited information provided, it would be inappropriate to speculate on what may or may not have led to the reported occlusion of the ivc. 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 according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014. " "on or about (b)(6) 2015, [pt] presented for removal of ivc filter. At that time, removal of the retrieval ivc filter was not accomplished secondary to complete total occlusion of the inferior vena cava below the filter. " patient outcome: it is alleged that "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] has suffered emotional trauma, harm and injuries that will continue into the future. [pt] has lost his ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] has lost earnings and will continue to lose earnings into the future and have medical bills, both past and future, related to care because of the cook ivc filters¿ defects. ".
 
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Brand NameUNKNOWN
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 Key6180026
MDR Text Key62528075
Report Number3002808486-2016-01481
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
Report Date 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
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: 12/16/2016 Patient Sequence Number: 1
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