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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 Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Malposition of Device (2616); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Perforation of Vessels (2135); Injury (2348); Depression (2361); Blood Loss (2597); No Information (3190); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Corrected data: adverse event and product problem to product problem, serious injury to malfunction. 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 'tulip, migration, tilt, bleeding, pain'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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. Unknown if the reported bleeding, pain 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
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but refered to as a cook günther tulip filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057 investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014 at (b)(6)". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but refered to as a cook günther tulip filter. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Information regarding the event has not been provided. It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received. If additional information is received, the report will be re-opened for further investigation.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 04/25/2017 as follows: the plaintiff allegedly received an implant on (b)(6) 2014 via the femoral vein due to pe and dvt. The plaintiff alleges migration, tilt, bleeding, and pain.
 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6, dk-4632
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6, dk-4632
bjaeverskov
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov, IN 47404
8004574500
MDR Report Key5801654
MDR Text Key248248956
Report Number3002808486-2016-00732
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 Other,Consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2016
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
Distributor Facility Aware Date07/12/2016
Date Manufacturer Received02/14/2022
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: 07/18/2016 Patient Sequence Number: 1
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