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

MAUDE Adverse Event Report: COOK CELECT IVC FILTER

  • 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
 

COOK CELECT IVC FILTER Back to Search Results
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 12/20/2017
Event Type  Injury  
Event Description
Celect ivcf placed in (b)(6) 2010, failed retrieval attempt in 2010. Found to have 2 fractured arms of the filter. One immediately posterior to the ivc and one remote from the ivc in the retroperitoneum. The tip was embedded. The filter was removed successfully with forceps, but the fragments are extravascular and not accessible to a transvenous approach. Will follow with serial imaging.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCELECT
Type of DeviceIVC FILTER
Manufacturer (Section D)
COOK
bloomington IN
MDR Report Key7142234
MDR Text Key95742582
Report NumberMW5074193
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
-
-