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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 Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2017
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Summary of investigational findings: complete igtcfs-65-1-jug-celect-pt was returned and during investigation is was noted that the safety button was not pressed, ie the system was still locked. After unlocking the system and advancing the filter, it fully expanded and no damages were revealed. The diagonal width between primary filter legs was according to specifications. Based on these findings the exact reason, why the filter would not open and was possibly twisted cannot be determined. During the manufacturing/qc processes the spring effect of every filter is 100 % controlled, as they are all deployed after advancement through a testing sheath. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.
 
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-1-jug-celect-pt. Name and address for importer site: (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "during a procedure to place an ivc filter, the physician went to deploy the filter and felt that some of the legs did not open. So resheathed the device and tried to deploy again. As the legs still did not look good to the physician on angio, possibly twisted, the device was resheathed as it was in the patient and removed from the patient. Another of the same device was used to continue the procedure and it deployed as expected. " patient outcome: the patient did not require any additional procedures due to this occurrence and no adverse effects to the patient has been reported 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 Key6621267
MDR Text Key249794116
Report Number3002808486-2017-01240
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121629
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 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/15/2017
Device Age5 MO
Event Location No Information
Date Manufacturer Received05/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
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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