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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
Catalog Number IGTCFS-65-2-UNI-CELECT-PT
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Event Description
Description of event according to the initial reporter: the case was planned to place a ivc filter through femoral vein.They found high resistance during advancing the filter delivery system through the sheath, so they removed the filter delivery system from the sheath immediately.They reopened another new kit and advancing the new femoral delivery kit.Finally, the ivc filter was placed successfully.Patient outcome: no additional information regarding the patient and/or event has been received.
 
Manufacturer Narrative
Manufacturer ref# pr(b)(4).Similar to device marketed under pma/510(k): k171712.Investigation is still in progress.
 
Manufacturer Narrative
(b)(4).Similar to device marketed under pma/510(k): k171712.Investigation is still in progress.
 
Event Description
Description of event according to the initial reporter: the case was planned to place a ivc filter through femoral vein.They found high resistance during advancing the filter delivery system through the sheath, so they removed the filter delivery system from the sheath immediately.They reopened another new kit and advancing the new femoral delivery kit.Finally, the ivc filter was placed successfully.Patient outcome: no additional information regarding the patient and/or event has been received.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: resistance was felt when advancing the femoral introducer with filter through the sheath.The femoral introducer with filter was removed and the procedure was successfully completed with another device.The complete uni device was returned for investigation.The introducer dilator was kinked 454 and 506mm from distal end.The celect-pt filter was severely damaged with three filter legs being kinked/crossed and one of them pushing upwards against the clip bushing, likely because the filter was removed ¿from the sheath immediately¿.On the femoral introducer the red locking mechanism was pressed, ie the system was unlocked.No nonconformances were noted on the introducer sheath and the femoral introducer could be advanced without resistance.Based on these findings the exact reason for the difficulties encountered, when attempting to advance the femoral introducer cannot be determined, but reference is made to the instructions for use warning against rotating the preloaded filter inside the introducer system during advancement.Also, following advancement difficulties the ifu caution that attempts to retract the pre-expanded filter could damage the secondary filter legs or the caval wall.There are adequate controls in place to ensure that the device is manufactured to specifications.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6, dk-4632
bjaeverskov
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov 
MDR Report Key12932283
MDR Text Key285424815
Report Number3002808486-2021-02000
Device Sequence Number1
Product Code DTK
UDI-Device Identifier10827002345048
UDI-Public(01)10827002345048(17)240202(10)E4068555
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/02/2024
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device Lot NumberE4068555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2021
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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