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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problems Kinked (1339); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog# igtcfs-65-1-fem-celect-pt. (b)(4). Summary of investigational findings: investigation is based on description of event and returned product. During filter implant attempt, the sheath kinked and the filter became stuck in the sheath. Introducer with filter, the blue sheath, the long and short dilator have been returned. During product investigation 14 minor kinks were revealed in sheath and a pre-penetration 23 cm from tip. As described in event description the sheath was advanced femoral and based on the information provided the exact reason for the damaged sheath cannot be determined. However, under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: "upon filter implant attempt, the sheath kinked and the filter became stuck in the sheath. The introducer/sheath system became stuck at the junction of the left iliac vein and the common iliac. The physician felt resistance. He could see a kink in the introducer sheath upon fluoro. It could not be implanted and was pulled out. The procedure was successfully completed with another filter". 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 FEMORAL 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 Key7489711
MDR Text Key107573257
Report Number3002808486-2018-00524
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/16/2018
Device Age8 mo
Event Location No Information
Date Manufacturer Received02/16/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/06/2017
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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