• 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
Model Number G34505
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Great Vessel Perforation (2152); Device Embedded In Tissue or Plaque (3165)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

As initially reported to customer relations via phone discussion with the customer: female patient underwent a filter implant on (b)(6) 2015 in which the cook celect platinum navalign uniset vena cava filter set, g34505, was used. The patient presented for an unrelated issue to the hospital on (b)(6) 2019 which the physician ordered a ct scan. During the ct scan it was discovered that the tip of the filter had fractured and separated and penetrated the aorta. One leg perforated the left renal, one perforated the right kidney, and one is in the l4 vertebral body. No removal procedures to be done related to this however, due to patients overall general health status.

 
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
MDR Report Key9898099
MDR Text Key188823887
Report Number3005580113-2020-00316
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 03/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device MODEL NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device LOT NumberE3362007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2020
Distributor Facility Aware Date03/13/2020
Event Location Other
Date Report TO Manufacturer03/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/31/2015
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: 03/30/2020 Patient Sequence Number: 1
-
-