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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 FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT
Device Problem Difficult to Flush (1251)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-2-uni-celect. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: no product, photos or imaging received to support the investigation. Based on the very limited information it is not possible to conclude an exact root cause for the event cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: could not flush the side port. Proceeded with case and no further problems. Patient outcome: prior to patient contact.

 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5895770
MDR Text Key52725567
Report Number3002808486-2016-00926
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/25/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT
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 Received07/29/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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