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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
Model Number G34505
Device Problems Dent in Material (2526); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: a (b)(6) year old male underwent a vena cava filter implant. The physician was able to gain access; when inserted the filter into sheath up to approximately 5cm the filter would not advance any further. The filter did get past the valve. The physician removed the device and the company representative, who was present during the procedure, was able to provide another of the same device to complete the procedure with no further complications. Patient outcome: there was no harm to the patient and no additional procedure required.
 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key8168516
MDR Text Key130457628
Report Number3002808486-2018-01525
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2021
Device Model NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberE3772627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/03/2018
Device Age3 MO
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2018
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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