• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2011
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no images or product is returned to assist the investigation. Nothing from the available information indicate a product failure. Filter can be repositioned if the filter has not reached the desired position and filter is not released from the grasping hook. Therefore, it is important that placement of the filter is performed by fluoroscopic control. No evidence to suggest that product is not manufactures to current specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: ivc filter placement was performed. The physician intended to place the filter just below renal vein, but it was placed in iliac vein junction area by mistake. The filter was remained there and another filter was placed just below renal vein. Patient outcome: the patient is fine after the procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6275213
MDR Text Key65671914
Report Number3002808486-2017-00056
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
Report Date 12/16/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2011
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/09/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-