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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JP-JUG-TULIP
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# igtcfs-65-jp-jug-tulip. (b)(4). Similar to device under 510(k) k090140. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: the device was approached from the right jugular vein. The physician decided the target site, then pushed the metal knob of the filter introducer to place the filter. When he attempted to remove the introducer from the patient after that, the filter moved as if it was still connected to the introducer or being dragged by a thread although the filter appeared to be detached from the filter introducer. After several attempts of withdrawing and rotating the introducer, the filter could be detached from the introducer and placed. Patient outcome: there have been no adverse effects to the patient reported.

 
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Brand NameGÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
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 Key7482345
MDR Text Key107216926
Report Number3002808486-2018-00507
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/18/2019
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Device LOT NumberE3508181
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/18/2018
Device Age15 mo
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/18/2016
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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