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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 Advance (2920); Sharp Edges (4013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma/510(k): k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: ivc filter placement was performed in emergency by the right internal jugular vein approach. When the user was advancing the filter introducer through the previously placed sheath, he felt resistance. He checked what was wrong, then found that the filter penetrated the sheath and protruded. He managed to have the protruded part back into the sheath as much as possible by using an angio catheter and wire guide, then removed the entire device. The first device was replaced with another igtcfs-65-jp-jug-tulip of the same lot#, but because the same thing occurred at the same site, he removed the entire device by the same way as he did on the first device. The second device was replaced with gunther femoral approach device. The approach site was changed to the femoral as well and the procedure was completed with the third device. Patient outcome: there have been no adverse effects to the patient reported. It was confirmed that there was no damage to the vessel due to the event.

 
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Brand NameGÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
MDR Report Key10095572
MDR Text Key196585479
Report Number3002808486-2020-00567
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 05/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2020
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
Device LOT NumberE3964279
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 Received05/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/17/2020
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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