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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 05/01/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Catalog#: igtcfs-65-jp-jug-tulip. Similar to device under 510(k): k090140. (b)(4). Summary of investigational findings: the jugular introducer, sheath, stopcock, y- fitting and the long dilator is investigated. The filter was not returned. The investigation revealed that the introducer was bend in the handle end. However, no influence on the function. The radiopaque sheath has a minor bend in the handle end. The remaining of the returned parts of the device seems normal. There was no problem in advancing the dilator all the way through the sheath. Why "the anchors got caught in the sheath and eventually prevented the filter from exiting" is unknown. However, the introducer sheath shall not cover the anchors. The bends in the handle end on the introducer and the 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 and filter introducer through tortuous anatomy. The evaluation of the product did not indicate a device failure. 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: the device was used for ivc filter placement. There was no problem in the patient anatomy according to the physician's information. During the procedure, the filter would not exit the sheath. Whole delivery system was removed from the patient. When the user inspected the failure outside the patient, it was found that anchor/anchors was/were caught on the sheath, which eventually prevented the filter from exiting. Then, the user moved the sheath applying some force to try to make the filter exit, then the filter exited the sheath and expanded. However, the user decided not to use the device anymore in consideration of risk. Since there was no other gunther jug available, gunter fem was used instead after puncturing the fa and the filter was placed successfully. Patient outcome: there have been 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 Key6299606
MDR Text Key66438247
Report Number3002808486-2017-00270
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 05/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
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 Received05/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2013
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: 02/03/2017 Patient Sequence Number: 1
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