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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

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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 Misassembled (1398); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Occupation: unknown. Pma/510(k): k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: a patient of undisclosed gender and age underwent a filter implant procedure in which the cook celect platinum navalign uniset vena cava filter set, g34505, was used. The filter was inserted through the sheath and physician started to deploy. Physician pulled the filter out stating the filter was defective. Another of the same filter was used to continue and complete the procedure with no further complications. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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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
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key11403054
MDR Text Key238348465
Report Number3002808486-2021-00921
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/03/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device LOT NumberE4054002
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/18/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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