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 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-jug-celect-pt.(b)(4).Corrected data compared to medwatch report (b)(4): outcomes attributed to adverse events) other serious.Report date) 17aug2017.Brand name) celect platinum.Common device name) filter, intravascular, cardiovascular.Mfr info) cook inc.Model #/lot #) catalog#: g34309.Device available for evaluation?) yes.More than 10 days ago.Approximate age of device) 1 days, investigation is still in progress.

Event Description

Description of event according to medwatch report: "the inferior vena cava (ivc) filter device was not able to release from delivery system by operator: lidocaine 1% was infused for local anesthesia.Right internal jugular vein was patent by real-time sonography.Micropuncture technique was used to access the right internal jugular vein.The celect sheath was advanced into the right common iliac vein, and ivc gram was performed, revealing no evidence for thrombus in the imaged ivc.Under fluoroscopic guidance the filter was deployed.Initially, there was difficulty deploying the filter: after the safety button was pressed, the second deployment mechanism did not work initially.We attempted to re-sheath the filter, but this was also not successful.Eventually, the mechanism did detach, and the filter was deployed in the infra-renal location, in the exact location that we intended to deploy the filter.Afterwards we did not obtain an ivc gram, as the sheath was not functional." patient outcome: unknown.

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 and returned device.Except from the filter the complete device was returned.The jugular introducer was placed inside the blue sheath and both were kinked close to the sheath handle.The introducer was locked in hardened blood and consequently the release mechanism did not work.To remove and investigate the grasping hook itself the introducer was cut and the hook was found in normal shape and without any damage, thus indicating that the introducer/hook had worked as intended.Based on these findings the exact reason for the difficulties encountered when attempting to release the filter cannot be determined, but 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 was deployed in intended location.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.

• 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: 6921505
• MDR Text Key: 89593788
• Report Number: 3002808486-2017-01924
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)200515(10)E3585069
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• 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?: No
• Distributor Facility Aware Date: 09/12/2017
• Device Age: 2 MO
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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: 60 YR