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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
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Similar to device under pma/510(k) k171712. Investigation is still in progress.

 
Event Description

When the physician pushed the filter introducer (preloaded with filter) in the guide sheath, he felt resistance and couldn't pass smoothly through the guide sheath, so he strengthened in pushing, and he found ivc filter hook perforate the sheath, but no damage on vessel. He removed the guide sheath and found tortuous common iliac vein (civ) anatomy make the sheath kinked. He replaced with a new one and finished the procedure. Patient did not require any additional procedures due to this occurence.

 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key9961160
MDR Text Key198519289
Report Number3002808486-2020-00402
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device LOT NumberE3904015
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2019
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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