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

Model Number	G34502
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3002808486-2023-00059
• Device Sequence Number: 5899312
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)251215(10)E4347528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2025
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E4347528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female