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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problem Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(4). (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: for an ivc filter placement via the right internal jugular vein the cook celect platinum navalign jugular vena cava filter set was used. The jugular filter would not deploy. Access through right internal jugular vein. Filter was unsheathed but would not deploy. Another filter was used without fail. Physician had to resheath the defected filter, remove it from the patient then place a second filter through the existing access. Patient outcome: no injury to patient. Extended the procedure time for the patient.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN JUGULAR 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 Key7766585
MDR Text Key116537051
Report Number3002808486-2018-00912
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
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,Followup
Report Date 10/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Device LOT NumberE3710521
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/23/2018
Device Age3 mo
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/06/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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