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

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

Device Problems Difficult to Advance (2920); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Description of event according to initial reporter: steps of procedure: gained access of right jugular vein with short 6f sheath, placed wire.Did a run and marked lowest renal vein.Exchanged short 6f sheath with filter sheath included in pack over wire.Struggled to access with filter sheath, but eventually placed it.Removed dilator and wire.Was not able to push filter through sheath and realized the filter sheath had a kink in it.The physician decided to straiten sheath with dilator which resulted in puncturing the sheath.We had to open a second filter to be able to proceed with procedure.Physician decided to access the left jugular vein and filter was placed successfully.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

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Received by manufacturer 03oct2023 and assessed not reportable however investigation findings change assessment to reportable 30nov2023.G4) similar to device under pma/510(k) k211875.Summary of investigational findings: struggled to advance the coaxial introducer system over the wire, but eventually sheath was placed.After removing dilator and wire a kink in the sheath prevented advancement of the filter, why the filter was removed and the dilator was re-advanced to straighten the sheath, but the dilator punctured the sheath.Another filter was successfully placed.No device was returned for analysis, but a photo provided showed a sheath with two kinks and with a penetration in one of them.Since neither distal nor proximal end of the sheath is visible on the photo, it cannot be determined where in the sheath the kinks/penetration are located.Based on the photo provided it cannot be determined, what had penetrated the sheath, but based on the information provided it may have been a filter leg; likely the sheath kinked during the reported ¿struggle to access¿ and said kink prevented advancement of the jugular introducer/filter and resulted in a primary filter leg to penetrate the kinked sheath.However, this is pure speculation since neither the sheath, nor the dilator was returned for analysis.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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.

• 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 (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18309666
• MDR Text Key: 330273595
• Report Number: 3002808486-2023-00296
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-JUG-CELECT-PT
• Device Lot Number: E4423581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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