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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 Problems Malposition of Device (2616); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
Patient Problem Perforation of Vessels (2135)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: implanted (b)(6) 2018. Ct on (b)(6) 2018 revealed that leg was bent up and the filter was tilted all the way toward the wall and next to the renal artery. No separation. They were that it would not catch thrombus so it was retrieved. Retrieval was successful and a new filter was successfully implanted. The implanted filter penetrated the caval wall. Patient outcome: the patient did required additional procedures due to this occurrence: retrieval and replacement 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 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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key8314115
MDR Text Key135343107
Report Number3002808486-2019-00184
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2021
Device Model NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Device Lot NumberE3773730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/25/2019
Device Age4 MO
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/07/2019 Patient Sequence Number: 1
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