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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). 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 vena cava filter placement in which the cook celect platinum navalign femoral vena cava filter set, (b)(4) , was used. The medical staff tried to load the filter in to the hub of the celect device. The filter would not go in the hub. It just stopped. It would not advance to be loaded. They opened a different box, same g#, and it loaded perfectly fine. The case was completed. Patient outcome: the patient did not require any additional procedures due to this occurrence. Prior to patient contact. 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 FEMORAL 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 Key11441512
MDR Text Key247001567
Report Number3002808486-2021-00927
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE4004791
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/06/2020
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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