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

Model Number G34505

Device Problem Difficult to Advance (2920)

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

Event Date 08/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) k171712.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.

Event Description

Description of event according to initial reporter: while attempting to deploy a celect filter on sat (b)(6) 2021, the filter went through the side of the blue sheath that is included with the set.Fortunately the physician was able to retract the filter back into the sheath and pull both the filter and the blue sheath out.The filter was damaged in the process but was fortunately fully intact.The hospital saved the damaged filter.After this incident the physician immediately opened a second cook celect filter and successfully placed the second filter in the patient without incident.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: the filter penetrated the blue sheath and was pulled back into the sheath and both were retrieved.The filter was damaged, but no harm to the patient was reported.The femoral introducer, the jugular introducer, the coaxial introducer sheath system, and the celect-pt filter were returned.The femoral introducer was returned inside the sheath and the loaded filter had penetrated the sheath wall 235mm from the distal end.Also, the sheath was squeezed 130-153mm from the distal tip and kinked/squeezed 43-51mm from same.The penetrated filter was severely damaged with the secondary filter legs bending upwards against the clip bushing, likely because reportedly the filter was pulled back into the sheath for retrieval from the patient.No imaging was provided and based on the information received the exact reason for the advancement difficulties cannot be determined.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and following, the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.The instructions for use warn that excessive force should not be exerted to advance the filter through the sheath.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, 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.

Event Description

Additional information received 26aug2021: no unintended section of the device remain inside the patient¿s body.The patient did not experience a delay or require any additional procedure due to this occurrence.No adverse effects on the patient due to this occurrence.The product did not caused or contributed to the adverse effects.No surgical / medical intervention performed due to the experienced difficulty.

• 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 ; 56868686
• MDR Report Key: 12458733
• MDR Text Key: 271046681
• Report Number: 3002808486-2021-01783
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)240419(10)E4099835
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E4099835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1