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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JP-FEM-TULIP
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2012
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-jp-fem-tulip. Similar to device under 510(k): k090140. (b)(4). Summary of investigational findings: we conclude that the physician had difficulties placing the filter. This has most likely damaged the filter as reported. The specific package insert states that any attempt to reload the filter may damage the introducer or the filter. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: the filter leg deformed when the physician advanced the sheath again to change position after the filter was out of the sheath tip as pulling the sheath. However he continued placement and the filter was placed. The filter will be placed eternally as planned originally. Patient outcome: the patient has not complained of pain or anything and shown any problematic symptoms so far.

 
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Brand NameGÜNTHER TULIP VENA CAVA FEMORAL 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 Key6299601
MDR Text Key66449982
Report Number3002808486-2017-00288
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 10/03/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JP-FEM-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 Received10/03/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2011
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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