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 Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).G4) 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 sheath of the filter sheath broke into coming from the left internal jugular at an acute angle, broke into and retrieved with a balloon catheter.They used another uni-celect ivc filter and they were successful.There was no patient complication.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: approach was done by the left jugular vein.The anatomy was such that they had to make a 90 degree turn to access the superior vena cava and it was difficult traversing the right angle turn.The introducer sheath broke in the patient and the broken part was retrieved with a balloon catheter.Another filter set was used and the filter placement was successful.No adverse event to the patient was reported.An introducer sheath and a non-cook balloon was returned and evaluated.The introducer sheath was fractured in two parts, which was severely deformed near the fracture.The proximal part of the introducer sheath (attached to the hub) had a kink and was narrowed and folded near the fracture.The distal part of the introducer sheath (with the tip) had a tear and was widened.This could be a result of the introducer sheath getting stuck in the 90 degree angle, resulting in a severe kink, which may have led to twisting and pulling of the sheath.Furthermore, the tip had an indentation, which is most likely a result of excessive force.It is likely that torturous anatomy could have led to difficult advancement resulting in excessive force exerted while advancing the introducer sheath followed by the filter introducer with the filter through the introducer sheath.The ifu warns that if severe resistance is met when advancing the wire guide or the introducer system, then the user must retract and choose a different approach.Excessive force should not be exerted.Furthermore, ifu states that for jugular filter placement, the right jugular vein is usually preferred due to its straighter route to the vena cava.An approach via the left jugular vein may be possible, depending on the patients size and anatomy.It is unknown why approach was made by the left jugular vein.Review of the device history record gave no indication of the device being produced out of specification.There are adequate controls in place to ensure the device was manufactured 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.

• 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 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 19916883
• Report Number: 3002808486-2024-00148
• Device Sequence Number: 7361287
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)270531(10)E4557635
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 10/08/2024

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: E4557635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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: Unknown