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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); Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: a mark which is almost a penetration is located approx. 26 cm from the fitting, a penetration is located approx. 27. 5 cm from the fitting, a minor kink is located approx. 33 cm from the fitting and furthermore, another mark which is almost a penetration is located approx. 33 cm from the fitting. It is presumed that difficult access is the root cause for this event. The kink and perforation marks on the introducer sheath indicate that excessive force has been applied when the introducer was advanced. Under normal conditions the sheath is strong enough to accomplish the procedure, but the introducer sheath may bend if excessive force is used to advance the introducer sheath and filter introducer through tortuous anatomy. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to initial reporter: a male patient underwent ivc filter placement by right jugular approach. The anatomy of the patient was suitable for the procedure. When the physician was advancing the filter into the lesion through the sheath, resistance was felt. Therefore, the situation of the device was checked under fluoroscopic control, which confirmed that the leg of the filter was penetrating the sheath. As the filter could be retracted back into the sheath by withdrawing the introducer a little, the whole system was retrieved out of the body carefully. The retrieved sheath was checked outside the body, confirming the mark of the penetration on it. However, as there were no alternative filters at the stock of the hospital, after checking that filter advancement through this damaged sheath was possible outside the body, the sheath was flushed and reinserted into the body to continue the procedure. When advancing the filter into the lesion through the damaged sheath, resistance was felt at the same place where resistance was encountered last time. However, after confirming that no legs were penetrating the sheath under the fluoroscopic control, the whole system was advanced through the point where resistance was felt and the procedure was continued. The filter could be placed in the body finally. 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
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6275496
MDR Text Key65666381
Report Number3002808486-2017-00090
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
Report Date 07/01/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
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?
Event Location No Information
Date Manufacturer Received07/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2014
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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