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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-65-1-UNI-CELECT-PT
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(4).Catalog#: igtcfs-65-1-uni-celect-pt.(b)(6).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "the physician was using the femoral delivery system and the sheath was placed in the right iliac vein with the tip in the ivc.The physician was advancing the celect platinum delivery system when the filter went thru the sidewall of the sheath approximately 20 cm's from the distal tip of the sheath.The physician had to pull the entire delivery system out of the patient and open up a new filter kit to complete the procedure.Also, the patient had severe common iliac vein tortuosity".Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects reported on the patient due to this occurrence.
 
Event Description
Description of event according to initial reporter: "the physician was using the femoral delivery system and the sheath was placed in the right iliac vein with the tip in the ivc.The physician was advancing the celect platinum delivery system when the filter went thru the sidewall of the sheath approximately 20 cm's from the distal tip of the sheath.The physician had to pull the entire delivery system out of the patient and open up a new filter kit to complete the procedure.Also, the patient had severe common iliac vein tortuosity".Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects reported on the patient due to this occurrence.
 
Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Summary of investigational findings: investigation based on event description and returned device.Filter attached to femoral introducer returned inside the introducer sheath - penetrating through the sheath wall approx.17cm from the sheath tip.All secondary filter legs were bending upwards against the clip bushing, probably since attempts were made to retract the penetrated filter back into the sheath.No imaging was provided, but based on information provided, it is assumed that the "severe common iliac vein tortuosity" caused the sheath penetration.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 and nothing indicates that it did not perform as intended.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
MDR Report Key7572368
MDR Text Key110180562
Report Number3002808486-2018-00652
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/10/2018
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 Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Distributor Facility Aware Date05/16/2018
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received07/24/2018
Supplement Dates FDA Received08/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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