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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problem Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Aspiration/Inhalation (1725); Anxiety (2328); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect filter. (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 if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56. (b)(4). Catalog#: unknown but referred to as a cook celect filter. (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 if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.

 
Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2014" 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 03/17/2017 as follows: the patient allegedly received the device implant on (b)(6) 2014. The patient is alleging multi bilateral emboli post filter implant, shortness of breath, weakness, and anxiety.

 
Manufacturer Narrative

(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 "multi bilateral emboli post filter implant, shortness of breath, weakness, and anxiety. " cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism 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

Exemption number e2016032e. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

The patient allegedly received the device implant on (b)(6) 2014 due to pulmonary embolism. The patient is alleging multi bilateral emboli post filter implant, shortness of breath, weakness.

 
Manufacturer Narrative

Exemption number e2016032. (b)(4). Investigation - investigation is reopened due to additional information provided. 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 "celect-pt - multi bilateral emboli post filter implant (pe), shortness of breath, weakness, anxiety. ". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. Unknown if the reported weakness or anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this time. No relevant notes found in device work order. No other complaints found in device lot. Product is manufactured and inspected according to manufacturing instructions and quality control. 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® PLATINUM NAVALIGN FEMORAL 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
sandet 6
bjaeverskov 4632, IN DK-46-32
DA   DK-4632
8004574500
MDR Report Key6338500
MDR Text Key67648110
Report Number3002808486-2017-00551
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
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,Followup
Report Date 06/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/13/2017
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/03/2014
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: 02/17/2017 Patient Sequence Number: 1
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