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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 Bent (1059); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer ref# (b)(4). Summary of investigational findings: the jugular introducer, the sheath, the filter, and the wire guide were returned. A penetration was noted on the sheath approx. 16 cm from the fitting. The primary filter leg penetrating the sheath was intact and without any damages, but one of the secondary legs was out of shape, probably due to the penetration. It is noted that a new device was used to complete the procedure. Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy. The ifu states that 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-jp-jug-tulip. Name and address for importer site: (b)(4). Similar to device under 510(k): k090140. (b)(4). Investigation is still in progress.
 
Event Description
Description according to initial reporter: access was gained from right jugular vein to perform placement of ivc filter. First, introducer sheath system was advanced over the wire guide (0. 035 inch) and removed the wire guide and introducer dilator. Then, filter introducer was attempted to advance into the sheath, however the filter leg(s) perforated the sheath where exited from the patient's body. Since a part of filter leg has bent, the physician determined it is risky if this system keep using. Therefore, another manufacture's device (cordis\optease) was used instead to complete the procedure. Patient outcome: there have been no adverse effects to the patient reported.
 
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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 Key6528739
MDR Text Key212965612
Report Number3002808486-2017-01002
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 04/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2017
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/06/2017
Device Age7 MO
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2016
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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