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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34309
Device Problems Material Protrusion/Extrusion (2979); Torn Material (3024); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: "they were trying to insert the jugular ivc filter into the subclavian vein and in doing so they could not get the filter to track around the turn correctly. The filter split the side of the deployment system. It split the internal deployment system and the blue external sheath. They withdrew the filter and put in a ivc filter from another manufacturer. " 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 JUGULAR 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 DK-46-32
DA   DK-4632
56868686
MDR Report Key7159482
MDR Text Key96477911
Report Number3002808486-2017-02541
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/07/2017
Device Age8 mo
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2017
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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