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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 Insufficient Information (3190)
Patient Problems Edema (1820); Thrombosis (2100)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Name and address for importer site: (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 initial reporter: it is alleged that "[pt] received a cook gunther tulip filter (b)(6) 2014". Patient outcome: [pt] alleges multiple dvt and lower extremity edema".
 
Manufacturer Narrative
Exemption number e2016032e lot. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 20feb2018 as follows: pt allegedly received an implant on (b)(6) 2014 via the right common femoral vein due to deep vein thrombosis. Pt is alleging multiple deep vein thrombosis after implant and bilateral lower extremity edema.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). Investigation: 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 ¿alleged multiple dvt and lower extremity edema". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Unknown if the reported multiple dvt after filter or lower extremity edema after filter placement is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Rpn and/or lot# are/is unknown, but the filter tulip is manufactured and inspected according to specifications. 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.
 
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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 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key7326359
MDR Text Key102129754
Report Number3002808486-2018-00337
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 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
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 Date03/02/2018
Event Location No Information
Date Manufacturer Received03/26/2018
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

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