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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 or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2017
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). (b)(4). Summary of investigational findings: the filter was returned with the jugular introducer. The grasping hook on the introducer was slightly straightened, but can still grasp and hold the filter. The filter is intact and without any damages. Based on these findings and since no imaging was provided the exact reason for the difficulties encountered cannot be determined, but since reported that the entire system was removed from the patient after the physician "felt strange feeling while expanding the filter", it is assumed that the filter would not deploy from the introducer. No evidence to suggest that product was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: the filter was returned with the jugular introducer. The grasping hook on the introducer can still grasp and hold the filter, but was slightly straightened. The filter is intact and without any damages and expands as expected. Based on these findings and since no imaging was provided the exact reason why the filter would not expand cannot be determined. However, it is seen before that the filter legs can be somehow obstructed from fully expanding due to e. G. Ivc anatomical conditions, clots or if the filter is not placed in ivc. It is noted that patient did not experience any adverse effects. During the manufacturing/qc processes the spring effect of every filter is 100 % controlled, as they are all deployed after advancement through a sheath. 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). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: a female patient underwent ivc filter placement. The patient's anatomical forms were suitable for the procedure, however, blood vessel tortuous was observed due to malformation of blood vessel running. Igtcfs-65-jp-jug-tulip was advanced from right jugular vein. While advancement, the physician felt some resistance. After he advanced the filter at the target lesion and attempted to expand the filter, however, he felt strange feeling while expanding the filter. Since there was some resistance while advancement also, he removed the entire system from the patient¿s body. Another device of the same rpn was used by left jugular approach to complete the procedure without problems. Additional information received 02may2017: i think thrombus etc. Contributed to expansion defect of filter leg(s) when its placement. Patient outcome: there have been no adverse effect 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 Key6571547
MDR Text Key211226651
Report Number3002808486-2017-01083
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,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2017
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 Date04/26/2017
Device Age6 MO
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2016
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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