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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 Alteration In Body Temperature (2682)
Event Date 02/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Similar to device under 510(k) (b)(4). (b)(4). Summary of investigational findings: the product was not returned and without the actual complaint device the exact reason for the difficult filter release cannot be determined. Additionally the approach was not reported, but it is assumed that the approach was from femoral vein, as on the image provided the secondary legs bent upwards, as if attempts had been made to pull the pre-exposed filter back into the sheath. Ifu, warning: excessive force should not be used to place the filter. The pre-exposed filter can be advanced, but never pulled back into the sheath. Doing so will damage the shape of the filter. There is no evidence to suggest the product was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
The filter cannot be released while the filter delivery system was delivered to the target site repetitiously. Then the physician retrieve the filter set to the delivery system and released again, the filter be released successfully this time. Patient outcome: no adverse effect to the patient 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
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6272093
MDR Text Key65573437
Report Number3002808486-2017-00061
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 03/02/2015
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-UNI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/09/2014
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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