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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52918
Device Problems Bent (1059); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Name and address for importer site: (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: device was placed via femoral approach. Once the filter was unsheathed, it was noted that the secondary struts were bent. The filter was removed with a gtrs-200-rb via jugular approach. A second igtcfs-65-1-uni-tulip was placed to successfully complete the procedure. Patient outcome: the device did cause or contribute to the need for additional procedures: the device was removed and another device was placed.

 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
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 Key7439071
MDR Text Key105754345
Report Number3002808486-2018-00461
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/21/2021
Device MODEL NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Device LOT NumberE3692849
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/03/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/03/2018
Device Age1 mo
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/21/2018
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: 04/18/2018 Patient Sequence Number: 1
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