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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 to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Thrombus (2101); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It is alleged that "[pt] received a cook celect vena cava filter on (b)(6) 2016. Hospital and medical records have been requested but not yet provided. " "on or about (b)(6) 2017 [pt] experienced severe pain in his leg, which required a 3-day hospitalization while. During this admission, he was diagnosed and treated for an occlusive thrombus which extended from the mid-femoral vain all the way to the popliteal vein; bilateral pulmonary embolisms; as well as heart strain caused by the aforementioned pulmonary embolisms. " "on or about (b)(6) 2018, the ivc filter was attempted to be removed from [pt]; this retrieval attempt was unsuccessful. " "on or about (b)(6) 2019, ct imaging showed at least one ivc filter "arm" perforating outside of the inferior vena cava lumen in [pt]. " "on or about (b)(6) 2019, [pt] underwent his second unsuccessful filter retrieval attempt. Ultimately, [pt] was referred to another hospital for exploration of further surgical removal options, which is ongoing. ".

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key9928911
MDR Text Key188825998
Report Number3005580113-2020-00346
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 Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/06/2020
Distributor Facility Aware Date03/19/2020
Event Location Other
Date Report TO Manufacturer03/18/2020
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: 04/06/2020 Patient Sequence Number: 1
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