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

Model Number	G34505
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): k233680 investigation is still in progress.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 celect filter appeared fine before insertion, but after being introduced to the patient, it appeared significantly tilted on the imaging screen.As a result, the doctor had to remove it and replace it with a new filter to ensure patient safety.Patient outcome: no harm to patient reported.
Event or Problem Description
Additional information received 09sep2025: the procedural approach was jugular.
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).Summary of investigational findings: the celect-pt filter appeared significantly tilted after placement from jugular approach.The filter was removed and replaced with no reported adverse effects on the patient.The complaint reported by the user was confirmed.The complaint is confirmed based on customer and/or sales representative testimony.Photographic evidence was returned for evaluation.The review of the photos determined the following: two photos of the celect-pt filter with an intact hook, but two or more misplaced secondary filter legs.A review of the manufacturing records and/or specifications did not reveal any discrepancies/nonconformances that could have contributed to this complaint issue.The investigation concludes the complaint device was manufactured to specification.The review of the relevant manufacturing records confirms the failure has not previously occurred for this manufacturing lot.There is no evidence to suggest that the user did not follow the instructions for use and/or label.A definitive cause could not be determined from the investigation.Possible causes are advancement during filter release or manipulation during attempt to re-sheath.An internal action is not deemed necessary at this time.Trending will monitor if any future actions are required.After considering this event the risk associated with the use of this device is still deemed adequate.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56868382
• MDR Report Key: 23023487
• Report Number: 3002808486-2025-00201
• Device Sequence Number: 9582120
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)280623(10)E4721078
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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 Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E4721078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female