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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 Problems Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Date 04/13/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: during a right femoral approach, the filter ripped through the sidewall of the sheath and needed to be removed so a subsequent filter could be placed. The physician encountered resistance as he was advancing the filter. The physician continued to advance the filter and the patient experienced pain at which point, the filter and delivery system was attempted to be removed. The sheath was cut and everything safely removed. They physician rewired thru the cut sheath. They then took a venogram of the right leg and there was no extravasation noted. Thus, a subsequent device was placed successfully. No tortuosity that would explain the resistance was encountered. Patient outcome: the patient experienced pain, which was resolved when the complaint filter was removed from the patient.

 
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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 Key6528740
MDR Text Key74075510
Report Number3002808486-2017-01021
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 04/14/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2017
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 Date04/14/2017
Device Age4 mo
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/14/2016
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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