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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 Activation Problem (4042)
Patient Problem No Information (3190)
Event Date 05/22/2019
Event Type  Malfunction  
Manufacturer Narrative

Manufacturers ref# (b)(4). Similar to device under pma/510(k): k171712. Summary of investigational findings: the investigation is based on the event description and the returned device. Only the femoral introducer was returned for investigation. Approx. 13. 4cm of the distal end was found slightly curved and the red safety button was pressed, ie the system was unlocked. The femoral cup stuck inside the introducer with hardened contrast/blood, but after dissolving it in water, the cup moved freely and the release mechanism worked as intended and was found according to specifications. During manufacturing processes there are adequate controls in place to ensure correct placement of the spring as well as correct position of the safety button and the release button in the handle. Therefore, the exact reason for the difficulties encountered cannot be determined, but since the release button was pressed and since reported that "the filter might be pre-released, so it was hard to move back the sheath when he wanted to release it", it is assumed that the filter unintendedly released from the unlocked introducer inside the sheath and that the hooks of the released primary filter legs caused the difficulties encountered when attempting to pull back the sheath. However, based on the information provided and since only the femoral introducer was returned, it is assumed that the filter was placed in the correct position without any adverse effects to the patient. The device history record was reviewed with no evidence to suggest that the 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: the red security button has been pressed before the filter is released. Additional information received 11jan2020: "the device was used on the patient, but i have confirmed with the doctor when the event happened. The doctor confirmed he didn¿t depress the red safety button before he wanted to release the filter. He thought it¿s hard to move back the sheath, checked the device then he saw the red safety button was depressed". Patient outcome: the patient did not require any additional procedures due to this occurrence. The complainant did not report any adverse effects on the patient due to this occurrence.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key9641258
MDR Text Key184057834
Report Number3002808486-2020-00123
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial
Report Date 01/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT-PT
Device LOT NumberE3808863
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/18/2018
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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