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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FEMORAL APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JP-FEM-TULIP
Device Problems Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-jp-fem-tulip. Similar to device under 510(k): k090140. (b)(4). Summary of investigational findings: no image provided and no product returned and therefore it is impossible to determine the reason why "the wire loop was correctly curved without deformation though, it could not catch the filter hook. " however, it is noted that this was the second unsuccessful retrieval attempt and therefore it is suggested that the unsuccessful attempt was related to the "placed filter was slightly tilted", as the tilt may caused difficulties in catching the filter hook. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. No evidence to suggest product was not manufactured to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: approach was gained from the right jugular vein. There was no issue with the patient vasculature. (b)(4): the placed filter was slightly tilted. Since the wire loop of the gtrs- (lot# e3471601) was not curved but straight, it could not catch the filter hook. Then, another gtrs- (lot# 6476462) was used instead. (b)(4): another gtrs- (lot# 6476462) was used instead. The wire loop was correctly curved without deformation though, it could not catch the filter hook. Therefore, the procedure was abandoned with no further action. Additional information is provided on 19dec2016: a name, lot# of the implanted filter and implanted date are provided; "igtcfs-65-jp-fem-tulip/ e3185859", implanted on (b)(6) 016. Patient outcome: there have been no adverse effects to the patient reported.

 
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Brand NameGÜNTHER TULIP VENA CAVA FEMORAL 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 Key6212119
MDR Text Key63627895
Report Number3002808486-2016-01577
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JP-FEM-TULIP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/24/2014
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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