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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 Problems Difficult to Advance (2920); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturer ref# (b)(4). Blank fields on this form indicate the information is unknown or unavailable. Pma/510(k) k171712. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: a patient of unknown age and gender underwent a filter placement in which the celect platinum navalign femoral vena cava filter set, g34502, was used. The staff loaded the filter in the device hook first. It felt tight and when they [medical staff] pulled the hook out it was straight. The rest of the device was retrieved and another celect platinum device was used to complete the procedure. 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 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
thomas hessner kirk
sandet 6
bjaeverskov 4632 
MDR Report Key8904984
MDR Text Key158868342
Report Number3002808486-2019-01222
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
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device Lot NumberE3850983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2019
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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