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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52918
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under 510(k): k090140. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: the physician did not like where the filter was placed and recaptured the filter to reposition before completely deploying the filter. The filter came off of the delivery system and went into the introducer. The introducer was removed from the patient with the filter inside. The procedure was completed with another filter. Patient outcome: the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & 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 Key6344648
MDR Text Key67867180
Report Number3002808486-2017-00593
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
Type of Report Initial,Followup
Report Date 02/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/10/2017
Device Age4 mo
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2016
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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