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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT
Device Problems Occlusion Within Device (1423); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog#: unknown but referred to as a cook günther tulip filter. (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, ¿gunther tulip filter implanted". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.

 
Event Description

It is alleged that "patient received a gunther tulip filter on (b)(6) 2013". It is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

Exemption number e2016032. (b)(4).

 
Event Description

This additional information received on 08jun2018 as follows: pt allegedly received an implant on (b)(6) 2013 via the left femoral vein due to dvt. Pt is alleging tilt, vc perforation, unable to retrieve and filter thrombosis. Pt. Further alleges swollen, painful legs, cramps, wounds that won't heal, pain and back pain. It if further alleged, as per operative notes, that patient underwent operative intervention to resolve filter occlusion.

 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
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 DK-46-32
DA   DK-4632
56868686
MDR Report Key7551954
MDR Text Key109480683
Report Number3002808486-2018-00626
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/07/2016
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT
Device LOT NumberE3084630
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/15/2018
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/07/2013
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: 05/30/2018 Patient Sequence Number: 1
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