MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G52918
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Occupation unknown.Pma/510(k): k172557.Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: a patient underwent an ivc filter placement procedure in where a gunther tulip vena cava filter was placed, access achieved via right groin.The tech asked the district manager if the filter would deploy without pushing the red button.District manager advised the red button had to be pushed.When removing the filter it was noted that the filter did not fully deploy.The filter was resheathed and went over all of filter except the hook.When trying to remove the hook got caught on the filter.The physician cut the device outside of the patient with wire cutters.Then used an 11fr sheath, unknown manufacture, and was able to cover the hook and removed successfully.Sutured up the right groin.Used a celect uni filter on left side to complete the procedure.Patient outcome: no additional information regarding the patients outcome has been received.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: it is assumed that the filter would not release from the femoral introducer and when re-sheathing for removal it was noted that it did not fully expand.The filter was re-sheathed for removal, but the hook got caught.The device was cut with wire cutters and the groin was sutured.No device was returned for analysis, but a photo provided showed the filter still attached to the femoral introducer and advanced all the way through the sheath with the secondary filter legs/blades severely damaged and pushed upwards against the hook.Based on the very limited information provided it is assumed that the filter did not release in the first place, maybe because the system was still locked, since doubt ¿if the filter would deploy without pushing the red button¿.According to the instructions for use the red safety button must be pushed to prepare filter release, when the filter position is verified and correct.There are adequate controls in place to ensure that the device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & 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: 12947708
• Report Number: 3002808486-2021-02004
• Device Sequence Number: 5188587
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)241001(10)E4166147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 10/01/2024
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Device Lot Number: E4166147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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