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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG-CELECT-PERM
Device Problem Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Pain (1994); Perforation (2001); No Information (3190)
Event Date 03/22/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog # unknown as information was not provided but referred to as cook celect filter. Expiration date: unknown as lot # is unknown. (b)(4). Since catalog is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. Mfr date ) unknown as lot # is unknown. Investigation is still in progress.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a celect filter on (b)(6) 2012. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

(b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation after further information is received and will supplement in accordance with 21 c. F. R. 803. 56 when appropriate.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a celect filter on (b)(6) 2012. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

This additional information was received on 04/07/2017 as follows: the plaintiff allegedly received the device implant on (b)(6) 2012 due to upper extremity dvt and extensive family history of dvts. The device was successfully removed on (b)(6) 2013. The plaintiff is alleging vena cava perforation, pain, difficulty breathing, and anxiety.

 
Manufacturer Narrative

Exemption number e2016032. William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer). Manufacturer reference # (b)(4). Corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "vena cava perforation, pain, difficulty breathing, and anxiety". Cook will reopen its investigation if further information is received. Unknown if the reported vena cava perforation, pain, difficulty breathing, and anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. 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.

 
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Brand NameCOOK CELECT JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6427066
MDR Text Key70625035
Report Number3002808486-2017-00854
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup
Report Date 07/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-JUG-CELECT-PERM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/13/2017
Device Age7 mo
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2012
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: 03/23/2017 Patient Sequence Number: 1
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