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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 Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Occupation: non-healthcare professional. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿tulip - tilt, vc perforation, pain, nausea, vomiting. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter. 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. Unknown if the reported pain is directly related to the filter. Unknown if the reported nausea and vomiting are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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 short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2013". Patient allegedly received 2 implant filters on (b)(6) 2013 due to post deep vein thrombosis and pulmonary embolism. Patient outcome: patient alleges tilt and vena cava perforation. Patient further alleges "abdominal pain, nausea/vomiting, constant abdominal pain, chronic generalized pain".

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key8463314
MDR Text Key145091848
Report Number3002808486-2019-00361
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
Report Date 03/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date03/14/2019
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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