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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 Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2017
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 went jugular.They tried to deploy and it would not release.They tried 3 different times.They tried to resheath and expose again into patient and it still would not release.Patient outcome: no adverse effects on the patients was reported, and no additional procedures was required due to this occurrence.
 
Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on description of event and returned product.The system is tested, and no errors are found; the filter releases without problems.The filter hook and the grasping hook are a bit deformed.The sheath tip is slightly chopped, indicating that the filter caught the sheath edge as it was re-sheated.The root cause for the reported unsuccessful filter release could not be determined.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of Device
DTK 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 Key6776293
MDR Text Key82945936
Report Number3002808486-2017-01592
Device Sequence Number1
Product Code DTK
UDI-Device Identifier10827002343099
UDI-Public(01)10827002343099(17)200504(10)E3581325
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Distributor Facility Aware Date07/13/2017
Device Age2 MO
Initial Date Manufacturer Received 07/13/2017
Initial Date FDA Received08/09/2017
Supplement Dates Manufacturer Received11/13/2017
Supplement Dates FDA Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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