• 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 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 DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Chest Pain (1776)
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Article: buda, k. Et al, a pericardial pin, elsevier, 2021, vol. 3. Investigation is still in progress.

 
Event Description

According to article: a patient with a history of vte and prior ivc filter placement presented with viral pericarditis which was treated with medication management; however, a foreign body with the rv wall was observed with one of the ivc filter struts absent compared to an image from 3 years prior. The patient underwent urgent mediastinal exploration, the filter strut removed, and ventricle repaired. The patient¿s post-operative recovery was unremarkable and the rest of the filter was removed percutaneously. Patient outcome: unknown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key12352664
MDR Text Key267623145
Report Number3002808486-2021-01750
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 LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
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: 08/23/2021 Patient Sequence Number: 1
-
-