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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problem Activation Failure (3270)

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

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "they deployed the first one and when they deployed it and removed the system, the filter didn't open.So they had to retrieve the filter.User had to use the cook gtrs to retrieve this filter.(b)(4).When they retrieved the first one, they put in and deployed the second one and it didn't open.This filter was also retrieved.(b)(4).When they retrieved the second one, they tried to put the third one in and the third one got stuck in the sheath.Then they pulled the whole system for the third one and put a fourth one and deployed it lower and it opened just fine.(b)(4).Additional time and retrieval required but all took place in the same procedure." patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that 4 filters were used in the same procedure.First filter was deployed but filter didn´t open.It was retrieved with a gtrs ((b)(4)).The second filter was also deployed but the filter didn´t open either.This filter was also retrieved ((b)(4)).When the third was tried to be placed the filter got stuck in the sheath.The device was removed, and a fourth device was used instead, the filter was deployed lower and opened just fine to complete the procedure ((b)(4)).Two celect-pt filters were returned for product evaluation ((b)(4) and (b)(4)).The filters were marked a and b.Filter a was without any observed nonconformances.Filter b had one secondary leg crossed with one primary leg, this was easy to align.After the alignment no nonconformances was observed.Based on the product evaluation the reported failure cannot be determined, but deployment in a clotted vein could prevent the filter expansion.It was assessed that because any discovered non-conformances were properly dispositioned before final inspection, there is evidence that the dhr was fully executed.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.According to the instruction for use potential adverse events that may occur include, but are not limited to, the following: failure of filter expansion/incomplete expansion there are adequate controls in place to ensure that this type of device is manufactured to specifications.Based on the provided information and product evaluation an exact cause is unknown.However, a likely cause is that the filter was deployed in an obstructed area which prevented the expansion of the filter since a filter deployed lower opened just fine.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12539083
• MDR Text Key: 273534835
• Report Number: 3002808486-2021-01838
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female