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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52917
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 08/25/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: "physician got access into right vein, he used the dilator, inserted the sheath removed the inter dilator, inserted the filter partway in, we did not click the back end together, he decided to re adjust his position and do another venogram, he removed the filter and the filter was damaged in the process. He has removed the filter before without any problems. " patient outcome: unknown.

 
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Brand NameGUNTHER TULIP 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 Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key6861033
MDR Text Key86008572
Report Number3002808486-2017-01818
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG52917
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/28/2017
Device Age2 mo
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2017
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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