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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 Problems Bent (1059); Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2012
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140 summary of investigational findings: introducer system returned. The knob was found bent as reported, but a thorough investigation did not reveal any marks or sign of weakness to the material, which could have caused the incident. It was reported that the physician straightened the knob after bending it and metal will fracture if exposed to such manipulation. Unable to determine reason for the difficulties encountered when attempting to release the filter in the first place and consequently the knob to bend, but excessive tension may have resulted in the deployment difficulties when pressing the release button and consequently "pushing the metal knob repeatedly" may have caused the knob to bend. Ifu: "excessive force should not be used to place the filter. " no evidence to suggest that device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: the device was used for ivc filter placement. The filter was inserted to the desired position and the physician pushed the metal knob to release the filter. However, the filter was not released. After pushing the metal knob repeatedly in an attempt of release, the knob got bent. The physician straightened the bent metal knob, and when he pushed the knob again, the filter was released. Patient outcome: there has been no adverse effects to the patient.
 
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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 Key6272094
MDR Text Key65572163
Report Number3002808486-2017-00063
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 02/16/2012
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2011
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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