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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 Date 04/03/2012
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Occupation: attorney. Pma/510(k): k171712. Investigation is still in progress.

 
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
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 4632
DA 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 4632
DA   4632
56868686
MDR Report Key11782280
MDR Text Key249201966
Report Number3002808486-2021-01176
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 Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/06/2021 Patient Sequence Number: 1
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