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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 Insert (1316); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under pma/510(k) k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial report: the device was used for the placement of an ivc filter, and the access was gained from the right jugular vein. After the insertion of the sheath, the physician attempted to deliver the filter. However, he felt resistance during the advancement of the filter and found that the leg of the filter protruded from the side of the sheath by performing cine angiography. Then, the physician exchanged the complaint device with a femoral approach gunther tulip to complete the procedure. Patient outcome. The patient reportedly experienced no adverse effects.

 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key8627072
MDR Text Key145618627
Report Number3002808486-2019-00627
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,Followup
Report Date 01/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/12/2019
Device Catalogue NumberIGTCFS-65-JP-JUG-TULIP
Device LOT NumberE3530126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/07/2019
Device Age30 mo
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/12/2016
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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