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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 Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2015
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: the investigation did not reveal any leakage from the sheath. According to the description the stopcock was connected to the hub. Also physician and sales rep comment on either the stopcock or the sheath had a crack/slit. However, the stopcock was not returned for investigation and no crack or slit was found on the returned sheath. Therefore the root cause cannot be determined. 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 sheath and dilator were inserted by jugular approach and advanced to the target site. A stopcock contained in the gunther set was connected to the hub and a syringe was attached to the stopcock. When the user pulled the plunger of the syringe to fill the sheath with blood, air was aspirated into the syringe. Though air was aspirated at every attempt, filter introducer was advanced into the sheath to perform filter placement. However because air was confirmed again, the physician decided to stop using the device and attempted to remove the filter introducer from the patient. Then, anchors of the filter legs were caught on the edge of the sheath. The sheath was not fully withdrawn but just up to the puncture site not to damage the puncture site with the exposed anchors and not to let the filter travel and be placed in undesired site. Then, the sheath outside the patient was cut off by the user near the point where the filter appeared to lodge. Since the filter became visible and touchable, the legs were closed by the user and the filter could be removed. After that, the remained section of the sheath was removed as well. Another device was used instead and the filter was placed with no air aspiration during the procedure. Patient outcome: the patient had a favorable outcome.

 
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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 Key6272435
MDR Text Key65580041
Report Number3002808486-2017-00074
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 08/07/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/11/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/03/2015
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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