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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 Filtration Problem (2941)
Patient Problem No Code Available (3191)
Event Date 02/13/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no imaging was provided and no product was returned. Based on the limited information provided, it would be inappropriate to speculate at what may or may not have occurred leading to the reported lung infarction. However, it is unknown if the filter was tilted and or if the filter contributed to cause pulmonal embolism and if the pe caused the lung infarction. No indication that this filter was not manufactured according to specifications and the exact root cause remains unknown based on the available information. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: on (b)(6) 2013, a filter was placed for prevention of lung infarction. There was no problem about the procedure. On (b)(6) 2013, the patient developed lung infarction and went into shock. Thrombolysis was performed and the patient recovered. Patient outcome: the patient recovered after thrombolysis.

 
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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 Key6292147
MDR Text Key66215187
Report Number3002808486-2017-00158
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 02/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/07/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/01/2017 Patient Sequence Number: 1
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