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

Model Number G34502

Device Problem Difficult to Insert (1316)

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

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Occupation: manager.Device marketed under pma/510(k): k211875.Summary of investigational findings: the physician stated the filter jumped out of the sheath.The physician did not feel the tactile bump on the delivery system that should have alerted to pause the advancement.The filter was attempted to be resheathed, but the secondary legs were bent pointing toward the patient's head.The physician then tried to retrieve it but could not get the clover snare to capture the hook.The physician used forceps to grasp the filter and advance a 16 fr sheath over the filter to retrieve it.As the sheath covered the secondary legs, the secondary legs straightened out to normal position.The forceps was used to release the filter and the physician deployed the filter successfully.According to the instruction for use once the femoral cup is past the tip of the introducer sheath, the secondary legs of the filter are expanded.Attempting to retract the filter at this point of the deployment sequence could damage the secondary legs or caval wall.The device was not returned for evaluation and no images from the procedure were available.With the information provided it is unknown what caused the filter to go through the introducer sheath.However, it is possible that the filter was not aligned with the introducer sheath tip which caused the filter to be placed outside in the ivc and the physician to feel the filter ¿jumped out¿ of the sheath but this is purely speculations.No evidence to suggest that the product was not manufactured according to specifications.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

Description of event according to initial reporter: the physician stated that the filter jumped out of the sheath.The physician did not feel the tactile bump on the delivery system that should have alerted him to pause the advancement.The physician tried to re-sheath the filter.The secondary legs were bent pointing toward the patient's head.The filter had not been released from the delivery system but could not be re-sheathed.They tried to retrieve it but could not get the clover snare to capture the hook.The physician used grasper forceps to grasp the filter and advance a 16 fr sheath over the filter to retrieve it.As the sheath covered the secondary legs, the grasper released the filter and the sheath came off.The legs then straightened out to the normal position.The physician proceeded to deploy the filter successfully.This problem did extend the time required to complete the procedure to around 4 hours.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

• 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
• MDR Report Key: 16511083
• MDR Text Key: 310953429
• Report Number: 3002808486-2023-00059
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)251215(10)E4347528
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4347528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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): Required Intervention
• Patient Sex: Female