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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 Fracture (1260); Difficult to Advance (2920); Migration (4003)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description

According to the initial reporter; patient allegedly received an implant on (b)(6) 2016 via the left common femoral vein due to deep vein thrombosis and pulmonary embolism (per operative report). The patient alleges migration. On (b)(6) 2017, per a report from retrieval report (successful); ¿impression: patent cranial femoral vein, iliac veins, including iliac vein stent, and inferior vena cava. Technically challenging ivc filter removal requiring the use of rigid forceps. Fragment of a secondary filter strut, which migrated to the right lower lobe pulmonary artery. Numerous attempts at removal of this fractured strut fragment were unsuccessful. Original: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016. " (b)(6) 2017: technically challenging ivc filter removal requiring the use of rigid forceps. Fragment of a secondary filter strut, which migrated to the right lower lobe pulmonary artery. Numerous attempts at removal of this fractured strut fragment were unsuccessful.

 
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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 Key9801123
MDR Text Key193019113
Report Number3005580113-2020-00282
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 02/25/2020,03/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2020
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
Distributor Facility Aware Date02/25/2020
Event Location Other
Date Report TO Manufacturer02/25/2020
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: 03/06/2020 Patient Sequence Number: 1
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