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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2013
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: investigation of the returned device showed that the grasping hook is out of the original shape. Based on the information provided, it was not possible to conclude an exact root cause for this event. The introducer system and filter are inspected prior to shipment. Therefore, it is considered highly unlikely that the product is shipped from manufacturer with these damages. No evidence to suggest that the grasping hook had "weak grasping hook function" as proposed by the physicians. The grasping hook was most likely pulled out of its shape during the procedure. Cook medical will continue to monitor for similar event.
 
Event Description
The procedure was conducted as labeled with the right internal jugular vein approach. The filter introducer was advanced into the sheath, then the filter was once expanded with the hook still connected to the introducer. The sheath was advanced over the filter next, but after that, the filter hook was detached from the grasping hook inside the sheath. Then, the whole delivery system was removed from the patient body since the filter was completely lodged inside the sheath. The physician connected the filter hook to grasping hook outside the patient body though, it felt that two hooks were not connected tightly. However, the physician continued the procedure with the device inserting the sheath first. The sheath was not advanced over the filter after filter expansion this time, and the filter was placed eventually. Patient outcome: no adverse effect to the patient due to this occurrence.
 
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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 Key6282022
MDR Text Key65903534
Report Number3002808486-2017-00109
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 12/12/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2017
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 Received12/12/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2013
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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