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 Failure to Unfold or Unwrap (1669)

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

Event Date 10/04/2022

Event Type  Injury  

Event Description

Description of event according to initial reporter: the filter legs couldn't be opened as usual, the doctor removed it and replaced another new one.Patient outcome: 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.Similar to device under 510(k) k211875.Investigation is still in progress.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the celect-pt filter would not expand and was retrieved by gtrs from jugular approach.Another filter was successfully placed without harm to the patient.The complete uni set was returned with the celect-pt filter still loaded to the femoral introducer by the primary filter legs.A kink was noted in the introducer sheath 364mm from the distal tip and two of the secondary filter legs were slightly misshaped, likely from attempt to retrieve the pre-expanded filter.No other non-conformances were noted on any of the components, and after release from the femoral introducer all the filter legs expanded according to specifications.No imaging was provided and based on the investigation findings the exact reason for the filter to not expand cannot be determined.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding, maybe if the filter is deployed in a thrombus, if the filter legs are caught in a clot, or if the filter is not placed in the ivc.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 qc 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 21cfr 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 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 (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15578613
• MDR Text Key: 301553980
• Report Number: 3002808486-2022-00974
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)230323(10)E3966193
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3966193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention