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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: the complete set is returned - except for the filter. The jugular introducer is unused. The femoral introducer is slightly bent. When pressing the release button, hardened blood was pushed out at the distal end. However, the piston moved freely and no damages were noted anywhere on introducer. It is assumed, that the secondary filter legs were not expanded as well, since filter was removed and "changed another product to finish the procedure. " however, since the filter was not returned and no images were provided, it is not possible to determine the root cause for why the "filter was not completely released during use as the primary filter leg was not completely open". No evidence to suggest product was not manufactured to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: the filter was not completely released during use as the primary leg was not completely open. Changed another product to finish the procedure. Patient outcome: the patient did not require any additional procedures due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
 
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Brand NameGUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key6275549
MDR Text Key65679368
Report Number3002808486-2017-00040
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/23/2013
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
Device Catalogue NumberIGTCFS-65-UNI
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2012
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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