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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34505
Device Problems Kinked (1339); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# igtcfs-65-1-uni-celect-pt. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: we were inserting an ivc filter today and ran into an issue. The sheath became kinked and the physician was unable to pass the deployment device. We took the sheath out and used a new kit without issue. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET 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 
56868686
MDR Report Key7008741
MDR Text Key92507068
Report Number3002808486-2017-02201
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34505
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/17/2017
Device Age4 mo
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2017
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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