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

Model Number G34309

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2017

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: after advancing the filter delivery system and unsheathing the filter per ifu, the physician attempted to release the filter by pressing on red safety button first then blue button.The filter hook seemed detached from the catheter and deployed but when the physician tried to pull back the delivery catheter to remove it from the sheath, the filter was still attached to the delivery catheter.He proceeded by tugging a little bit and heard a snap and filter came loose of the delivery catheter, this caused a minimal tilt which was not concerning to the physician.Patient was safe and procedure was completed successfully but when delivery catheter was removed, physician noticed that the hook wire that releases the filter hook was bent.Although this procedure was completed successfully it caused a concern." updated information: "after following up with the physician today and looking at the device, i will have to make a small correction to my notes below, the wire hook was not bent, since that's how it's engendered, the wire hook comes out sideways from the retrieval delivery system.I attached the video showing that filter was deployed but still attached to the delivery catheter after pressing the blue button, but it is not visible in this film that the wire hook was still attached to the filter after deployment.The second image shows filter after it was completely released." patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects to the patient 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 introducer and the blue sheath are returned - both are very bloody.However, the grasping hook can easily be advanced and grasps and releases a sample filter nicely.No errors was found.The root cause for the reported difficulty in deploying the filter cannot be determined.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

• 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 Key: 6405319
• MDR Text Key: 69947717
• Report Number: 3002808486-2017-00831
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)191018(10)E3508182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/03/2017
• Device Age: 5 MO
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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