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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 09/27/2013
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: a functional test using a water filled syringe noted blockage in the sidearm of the check-flo assembly. A destructive test noted excess adhesive in the sidearm fitting. An inspection step for occlusion is added, but the device was built prior to this change cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: "the product would not flush therefore not used and another cook filter used successfully. " patient outcome: unknown.

 
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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 Key5895779
MDR Text Key52728820
Report Number3002808486-2016-00927
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/03/2013
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2013
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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