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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); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: investigation is based on even description and returned product. The femoral introducer with loaded tulip filter was returned. Investigation found the filter shape according to specifications, but the filter hook was severely bent with no damage to the hook material. Based on these findings the exact reason for the bent filter hook cannot be determined, but since reported that the filter was advanced "incorrectly into the sheath", this is supposed to have caused the damage. It is noted that the procedure was completed with another filter. Ifu: excessive force should not be used to place the filter. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-1-uni-tulip. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: gaining access for this case was difficult. When inserting the filter delivery system into sheath, the doctor noticed that the hook of the filter was bent. The staff observed that the doctor tried to insert the delivery system incorrectly into the sheath and suspect that he bent the hook. They successfully completed the procedure with another filter. Patient outcome: the patient did not require any additional procedures due to this occurrence. No adverse effects to the patient due to this occurrence.
 
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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 Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key6607123
MDR Text Key250031302
Report Number3002808486-2017-01149
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/10/2017
Device Age1 MO
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2017
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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