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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 Thrombus (2101)
Event Date 03/04/2014
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k): k090140. (b)(4). Summary of investigational findings: based on the limited information provided, it is unknown if the filter performance was related to this occurrence and consequently the exact root cause for the reported pe recurred after ivc filter placement cannot be determined. No report of filter tilt/misplacement. No indication 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 complaint device was placed in the ivc on (b)(6) 2014, which was planned to be retrieved on (b)(6) 2014. After the filter placement, anticoagulation therapy had been performed, but on (b)(6) 2014, pe recurred though the filter was still in the ivc. As a result of the exam of the patient, it was suspected that the patient had the history of hit. Large amounts of the blood clots were observed not only in the pulmones, but also in the filter. The physician plans to begin thrombus resolution on (b)(6) 2014. Additional information received 19mar2014: as the possibility that the patient had hit was suspected, thrombus resolution was started on (b)(6) 2014. The physician determined to monitor the patient for a while. Likelihood that the filter retrieval will be performed in the future is low at the moment. Patient outcome: thrombus resolution was started on (b)(6) 2014.

 
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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 Key6275509
MDR Text Key65671160
Report Number3002808486-2017-00071
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,U
Reporter Occupation
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2017
Is This An Adverse Event Report? No
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 Received03/19/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/27/2013
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: 01/25/2017 Patient Sequence Number: 1
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