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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 Difficult to Remove (1528); Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Manufacturers ref# (b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare. Summary of investigational findings: the reported allegations have been investigated based on the information provided to date. Filter fracture has been reported and may be either symptomatic or asymptomatic. Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e. G. , a renal vein). Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported. Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures. Filter or filter fragment migration and (or) embolization (e. G. , movement to the heart or lungs) has been reported. Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic. Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: filter migration, trauma to adjacent structures. 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. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: it is alleged that "on an unknown date (but believed to be in 2010), [pt] was implanted with a cook celect ivc filter. On or about (b)(6) 2019, [pt] underwent a computerized tomography scan ("ct scan") of her abdomen and pelvis. On or about (b)(6) 2019, [pt] was informed that the ct scan revealed that the filter had fractured, with the fractured piece migrating into the right kidney. [pt]'s injury was inherently undiscoverable or objectively verifiable such that, despite [pt]'s reasonable diligence, she was unable to discover her injury until on or about (b)(6) 2019. " patient outcome: alleged that "[pt] faces numerous health risks, including the risks of death. Because the filter cannot be removed, [pt] will require ongoing medical care and monitoring for the rest of her life. ".

 
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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 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key10423829
MDR Text Key203479726
Report Number3002808486-2020-00779
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 10/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2020
Is This An Adverse Event Report? Yes
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
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

Patient TREATMENT DATA
Date Received: 08/19/2020 Patient Sequence Number: 1
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