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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G48373
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Name and address for importer site: (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "the physician noted one of the primary legs has perforated the duodenum". The filter was placed in 2014 because of hip fracture. Patient was bleeding. Filter was placed due to high risk of surgery. Due to the patients age, the physician has recommended not to remove the filter additional info received from district manager on (b)(6) 2018: placed (b)(6) 2014. This was an incidental find on a ct scan for sepsis. (b)(6) female. No attempt to retrieve patient outcome: the patient did not require any additional procedures due to this occurrence. No adverse effects to the patient reported due to this occurrence.
 
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Brand NameCOOK CELECT FEMORAL 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 Key8280675
MDR Text Key134178072
Report Number3002808486-2019-00105
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2016
Device Model NumberG48373
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Device Lot NumberE3243439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/02/2019
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2014
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: 01/28/2019 Patient Sequence Number: 1
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