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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52915
Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description

Description of event according to initial reporter: patient received a cook celect filter which tilted after placement and was immediately removed. New filter implanted.

 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key11811693
MDR Text Key250287766
Report Number3005580113-2021-00062
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/10/2021,05/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/04/2014
Device MODEL NumberG52915
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Device LOT NumberE2812236
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/20/2021
Event Location Hospital
Date Report TO Manufacturer05/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2011
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: 05/12/2021 Patient Sequence Number: 1
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