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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  Malfunction  
Manufacturer Narrative

Manufacturers ref# (b)(4). Pma/510(k) k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: the outer sheath had a kink or hole where the hub meets the blue outer sheath. The dilator was difficult to get through the hub but eventually it went through and inserted into the patient. The filter was still deployed and was deployed successfully. The final picture of the filter placement was unsuccessful as the contrast was leaking out of the hole where the hub meets the blue outer sheath. Procedure was completed successfully. Additional information received 12mar2020: filter was placed just fine. No tilt. Patient outcome: patient does have dvt. Patient was not effected at all.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN JUGULAR 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 Key9851828
MDR Text Key184058653
Report Number3002808486-2020-00332
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
Report Date 03/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Device LOT NumberE3937936
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2020
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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