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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 Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4) manufacturer ref# (b)(4) summary of investigational findings: investigation is based on event description only. No product was returned, but based on the information provided: "he continued the insertion of the filter into the sheath nevertheless", after noticing that the filter leg was bent. However, this is not according to ifu stating to "inspect the product to ensure no damage has occurred". The root cause for this incident is that the end user did not follow the ifu. It is noted that there is no effect to the patient, since the bent filter was not advanced. There is no evidence to suggest that the device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog# igtcfs-65-jp-jug-tulip. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: the sheath system contained in igtcfs-65-jp-jug-tulip was advanced to the ivc by right internal jugular approach. Then, the physician attempted to advance the filter into the sheath. However, prior to insertion, he noticed that one leg of the filter was bent. Therefore, another igtcfs-65-jp-jug-tulip (lot#:e3509642) was used instead and the procedure was completed with it successfully. Updated description with additional information received 4dec2017: a male patient with dvt underwent ivc filter placement. The sheath system contained in the igtcfs-65-jp-jug-tulip was advanced to the ivc by right internal jugular approach. After that, the physician attempted to advance the filter into the sheath. However, he noticed that one leg of the filter was bent then. He continued the insertion of the filter into the sheath nevertheless. However, the filter would not enter the sheath after all, but what was worse, its bent tip got broken (separated). Therefore, another igtcfs-65-jp-jug-tulip (lot#:e3509642) was used instead and the procedure was completed successfully. Since the filter got broken outside the body, no segments remained in the patient's body. 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
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7107420
MDR Text Key195838057
Report Number3002808486-2017-02405
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K090140
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 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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?
Distributor Facility Aware Date11/22/2017
Device Age13 MO
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2016
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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