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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-CELECT
Device Problem Insufficient Information (3190)
Patient Problems Blood Loss (2597); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Unknown if the following patient and device codes are listed in the ifu. Product information not provided. (b)(4). Name and address for importer site: (b)(4). Corrected data based on new information received: adverse event or product problem: adverse event to product problem. Serious injury to malfunction". The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 23/jan/2018 as follows: patient received an implant on (b)(6) 2011 due to deep vein thrombosis and pulmonary embolism. Patient is alleging bleeding due to the device.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). 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 'unknown filter, bleeding, pain/ suffering, disability/ impairment'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. 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.
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as an ivc filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] have suffered emotional trauma, harm and injuries that will continue into the future. [pt] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as an ivc filter. Expiration date: unknown as lot# is unknown. Name and address for importer site: (b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629. (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 of event according to initial reporter: it is alleged that "[pt] was implanted with an ivc filter and suffers ongoing injuries. " patient outcome: alleged that [pt] "have suffered permanent and continuous injuries, pain and suffering, disability and impairment. [pt] have suffered emotional trauma, harm and injuries that will continue into the future. [pt] have lost their ability to live a normal life, and will continue to be so diminished into the future. Furthermore, [pt] have lost earnings and will continue to lose earnings into the future and have medical bills both past and future related to care because of the ivc filters¿ defects. " hospital and medical records have been requested but not yet provided.
 
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Brand NameNAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key6401721
MDR Text Key250653135
Report Number3002808486-2017-00809
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/28/2017
Event Location No Information
Date Manufacturer Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/14/2017 Patient Sequence Number: 1
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