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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510k (2021 reports) k171712. Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: the case was planned to place a ivc filter through jugular vein. They found some resistance during advancing the filter delivery system through the sheath. Then they saw the filter delivery system is out of the sheath and is parallel with the long sheath. Finally, they removed the filter delivery system carefully through the broken part of sheath and out of patient body. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient did not require any additional procedures 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, dk-4632
bjaeverskov
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov 
56868686
MDR Report Key12364131
MDR Text Key268027560
Report Number3002808486-2021-01755
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 Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device Lot NumberE4068635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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