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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 Problems Difficult To Position (1467); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2014
Event Type  No Answer Provided  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no product returned and without actual complaint device the exact reason for the prereleased filter cannot be determined. However, since reported that physician "might have touched the metal knob or the red hub without notice" this is suggested to have caused it. Also, it is reported that attempts were made to retract the filter back into the sheath, but according package insert, filter placement 14, "if the filter is not in the desired position, carefully advance the sheath over the filter only the anchors. Reposition the system as desired, and again withdraw the sheath to the marker, completely exposing 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: a male patient underwent ivc filter placement by right jugular approach. The physician let the filter legs exit out of the sheath a little so as to deploy it, but the position of it was undesirable (just around renal vein). Therefore, he tried to retract the filter back into the sheath and modify the position. However, the filter had been already detached from the introducer in the sheath somehow and thus, was deployed and placed in unintended position (around renal vein). The deployed filter was retrieved and a new filter was placed in the target position successfully. Patient outcome: no adverse effects to the patient.

 
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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
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key6278358
MDR Text Key65764522
Report Number3002808486-2017-00130
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 07/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
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 Received07/28/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/07/2014
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: 01/26/2017 Patient Sequence Number: 1
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