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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-2-uni-celect-pt.(b)(4).Similar to device under 510(k) k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the ivc filter insertion case from the jugular access proceeded as normal to a situation whereupon the ivc filter was positioned in the ivc and ready to be released.The red safety button on the jugular deployment system was pressed before the blue 'release' button was released.Upon this release the ivc filter was partially seen to be released, and the blue 'release' button on the deployment system was released.The deployment system was then moved in order to be removed from the patient.However, as the deployment system was being retracted it was noticed that the ivc filter began to move - it seemed the deployment system was still attached to a part of the ivc filter.Gradual movement (up and down) was then required for a short period of time until it was presumed (visually and physically) that the deployment system was completely detached from the ivc filter.The deployment system was then retracted out of the sheath and a run was then completed.The ivc filter placement was still accurate and there was no observable trauma to the patient.The case was then completed to a successful conclusion.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.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description only.No imaging was provided and the product was not returned.Therefore, it would be inappropriate to speculate at what may or may not have led to the difficulties encountered when attempting to release the filter from the jugular introducer.However, reference is made to the ifu, warning that excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.It is noted that the filter placement was accurate and that the patient experienced no adverse effects.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

• 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 Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6826289
• MDR Text Key: 83897331
• Report Number: 3002808486-2017-01670
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)200503(10)E3581079
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/07/2017
• Device Age: 3 MO
• Date Manufacturer Received: 11/23/2017
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR