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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-UNI
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Similar to device under 510(k) k090140. Summary of investigational findings: the femoral metal part of the femoral introducer was returned. No filter returned. Furthermore, a 90 cm dilator and a flexor sheath are returned, no damages observed on these parts. However, this dilator and flexor sheath are not parts of this device set (igtcfs-65-uni). Visual inspection of the femoral metal introducer shows no signs of damages. According to the description, "the filter support wire pierced the sheath, which leading to the rupture of the sheath. " however, it is unknown what exactly happened during procedure and if the filter pierced the sheath. It is not possible to comment on the penetration as sheath and filter were not returned. Furthermore, the approach is unknown based on description and as the returned femoral introducer appears unused. Under normal conditions the sheath is strong enough to accomplish the procedure, but it has been seen before that the sheath may kink if somehow exposed to excessive force because of tortuous anatomy. If the filter is advanced through a kinked sheath, the filter legs may be prone to exceed the sheath wall. No indications 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: during the process of placing the filter, the filter support wire pierced the sheath, which led to the rupture of the sheath. They retrieved the device and replace with a new one. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameGUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
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 Key6275212
MDR Text Key65669728
Report Number3002808486-2017-00081
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 01/10/2013
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 HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-UNI
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2012
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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