• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Complete Blockage (1094); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Pain (1994); Thrombosis (2100); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (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 15mar2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2011 via the right internal jugular vein listed in the ppf] due to deep vein thrombosis. [pt] is alleging tilt, lifelong anticoagulant therapy. [pt] further alleges post-implant deep vein thrombosis , more blood clots, clogged filter, chronic pain in legs and mid-abdomen where the filter is located, chronic back issues. Per venacavogram filter was snared and repositioned on (b)(6) 2011 in adequate position (filter was tilted).
 
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 short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2011". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7107416
MDR Text Key266449523
Report Number3002808486-2017-02402
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
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 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
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?
Distributor Facility Aware Date11/21/2017
Event Location No Information
Date Manufacturer Received03/27/2018
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

Patient Treatment Data
Date Received: 12/12/2017 Patient Sequence Number: 1
-
-