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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 Malposition of Device (2616); Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2019
Event Type  Malfunction  
Manufacturer Narrative

Manufacturers ref# (b)(4). Occupation: special procedures technologist. 510(k): k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: "the physician attempted to put in a femoral celect filter. He deployed it and it landed crooked and one of the legs was sticking out at a weird angle. He then accessed the jugular vein, snared it, and attempted to deploy it again with the same result. At this point, he retrieved it and took it all the way out and placed a jugular celect filter with no issues. " additional information received on 09aug2019: the physician said the significant tilt occurred when he pushed the blue deployment button. The physician did mention when he deployed the filter that the secondary struts looked like they were somewhat "off" (position wise) on the right side. Please see image provided by dm. The physician indicated this is the first time he has ever seen this. Patient outcome: the product did cause and contribute to the need for additional procedures: had to access the right jugular vein to go in and retrieve the tilted procedure. Then place another one.

 
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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)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key8943811
MDR Text Key158617527
Report Number3002808486-2019-01332
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE3868489
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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