• 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 COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET 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 COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under pma/510(k) k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: ivc filter inserted via jugular approach. Physician states that he re-sheathed the filter on multiple occasions as wanting to achieve optimum position in the ivc. On one occasion when re-sheathing the filter it appears that the leg hooks have cut into the delivery guide tip, splitting it and snagging. The delivery hook appears to have snapped or bent out of shape when trying to retract the filter. Inserting via jugular, the filter appears to have cut into the delivery guide tip, splitting it and snagging. Thus the delivery hook snapped when we tried to retract the filter, as did a snare we managed to snare it with. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9966975
MDR Text Key195732211
Report Number3002808486-2020-00420
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device LOT NumberE3952204
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/12/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-