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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)
Patient Problems Chest Pain (1776); Perforation (2001)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Description of event according to the initial reporter. The filter was realigned as it was implanted crooked. The patient was sent home. After-which, the patient went to the (b)(6) hospital indicating she was experiencing chest pain. The physician at (b)(6) was able to substantiate the filter was crooked.

 
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Brand NameCOOK CELECT PLATINUM NAVALIGN 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)
COOK MEDICAL
sandet 6, dk-4632
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov DK-46-32
DA   DK-4632
30632506
MDR Report Key12179307
MDR Text Key261918565
Report Number3002808486-2021-01618
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE4060226
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/12/2021
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: 07/16/2021 Patient Sequence Number: 1
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