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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 12/08/2016
Event Type  Malfunction  
Manufacturer Narrative

Manufacturer ref# (b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a gunther tulip filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: gunther tulip tip was embedded which was discovered under retrieval of the filter. Patient outcome: unknown.

 
Manufacturer Narrative

Manufacturer ref# (b)(4). Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. Summary of investigational findings: investigation is solely based on description of event. No product was returned and no imaging was provided. According to the description of event, the "tip was embedded which was discovered under retrieval of the filter. " it is assumed, that the 'tip' is the filter hook, and that the filter retrieval was difficult - but successful. However, based on the limited information provided, it would be inappropriate to speculate on what may or may not have led to the reported tip embedded. 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. From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well known risk. Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. 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: gunther tulip tip was embedded which was discovered under retrieval of the filter. Patient outcome: unknown.

 
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Brand NameUNKNOWN
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 Key6212091
MDR Text Key63477317
Report Number3002808486-2016-01551
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2016
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 NumberUNKNOWN
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 Received12/13/2016
Was Device Evaluated By Manufacturer? No Answer Provided
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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