• 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 Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)
Patient Problems Occlusion (1984); Thrombus (2101); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Patient allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to history of pulmonary embolism(pe), per medical record received. Per a (b)(6) 2010 unsuccessful filter retrieval: "after several attempts, passage of the micro guidewire to the inferior vena cava was not possible, suggesting occlusion of the superior vena cava. Injection of contrast, also revealed tortuous, collateral venous filling in the neck. Impression: patent inferior vena cava with no clot formation noted. Getting access to the superior vena cava, because of the occlusion of the vein was not possible". Per a (b)(6) 2019 computed tomography (ct) abdomen: "ivc filter: there is an intact ivc filter with anterior tilt, 19. 1 degrees. Tip of the ivc filter is located at the level of the left renal vein and 2 cm superior to the right renal vein. Four of the struts extend 3 mm beyond the lumen of the the ivc at the right anterior, right posterior, left posterior, and left anterior aspects. There is calcified thrombus extending over a length of 2. 9 cm, extending 1. 1 cm superiorly from the tip of the ivc filter".

 
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
MDR Report Key9859789
MDR Text Key188825461
Report Number3005580113-2020-00295
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 03/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2020
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 FDA03/20/2020
Distributor Facility Aware Date03/04/2020
Event Location Other
Date Report TO Manufacturer03/03/2020
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: 03/20/2020 Patient Sequence Number: 1
-
-