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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 11/20/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) (b)(4). (b)(4). Summary of investigational findings: the tip of the introducer is cleaned in ultrasound. After that the grasping hook could be pushed out of the sheath. The grasping hook is compared to an approved grasping hook and no nonconformities is noted. Not a problem to attach a filter to the grasping hook either. Based on the returned introducer a root cause can not be found. It is seen before that to much bach tension while release button was pushed could cause deployment difficulties/failure when release button was pushed. Nothing in the description of the event gives evidence for "to much back tension", why the exact root cause can not be concluded. No evidence to suggest that device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
The patient had underwent placement of a (b)(6) protect in the cardiovascular surgical department but the filter has been migrated to the right atrium. Then placement of a günther tulip was performed on (b)(6) 2013 since (b)(6) protect was out of stock. The patient's anatomical form was suitable for the procedure. The sheath was inserted via the right internal jugular vein and the filter catheter was advanced without problems. Then the physician unlocked the red hub and pushed the metal button but the filter would not release. He attempted to release the filter by pushing the whole system or pushing the metal button for a long time but it would not release. So the sheath was advanced over the filter and metal button was pushed several times, then the filter finally released. 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 Key6272089
MDR Text Key65570233
Report Number3002808486-2017-00050
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 11/21/2013
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 Received11/21/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2013
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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