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

Model Number	G34309
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k): k211875.Summary of investigational findings: the filter would not deploy because the hook would not disengage from the filter.Another device was used instead to complete the procedure successfully.Jugular introducer and the filter were returned for evaluation.Blood and biological matter were present on the device.Filter was returned inside the protection sheath of the jugular introducer, there were no nonconformances observed on the filter.The grasping hook on the jugular introducer was covering the hook of the filter, there was no nonconformances observed on the grasping hook.The blue release button was very difficult to press and when the blue release button was depressed it would not come up again i.E., the grasping hook was stuck out.The handle on the jugular introducer was separated, there was no indication that the release button has been forced pressed before pushing the red safety button and no nonconformances were observed.A small kink near the welding and blood were observed on the grasping hook.The cause for the reported failure cannot be determined, based on the device evaluation.The observation with the blue release button was pressed down and could not come up again i.E., the grasping hook on the jugular introducer was stuck out, led to ric-2023-001 was initiated.It was assessed that because any discovered non-conformances were properly dispositioned before final inspection, 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.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 filter would not deploy because the hook would not disengage from the filter.Another filter was grabbed off the shelf (same one) and completed successfully.Patient outcome: the patient did not require any additional procedures due to this occurrence the complainant did not report any adverse effects to the patient due to this occurrence.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: lissi walmann ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 16793931
• Report Number: 3002808486-2023-00108
• Device Sequence Number: 7516149
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)250706(10)E4281965
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4281965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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
• Patient Sex: Unknown