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

Model Number	G52917
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a patient of unspecified gender and age underwent a vena stenting in the iliac procedure and the physician concluded the patient would also need a vena cava filter.Therefore a gunther tulip navalign femoral vena cava filter set, g52917, was used.Upon deploying approximately one third of the filter hook stuck inside branch of the inferior vena cava but could not tell which one.At this point the district manager was called the procedure to assist with the removal.The filter was not totally detached.The physician tried to pull back on the filter, however could not as there was a previously placed stent there.Then tried re-sheathing with the filter sheath, however the side arms became tangled inside and could not pull the side arms in.The device was deployed where it was with the feet deployed inside the stent in the left iliac.The physician ballooned and opened the feet and some feet were also in the right iliac.The filter was also deployed where it was as the patient was having discomfort while attempting to pull the filter out.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

• Brand Name: GUNTHER TULIP 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
• MDR Report Key: 15484446
• Report Number: 3005580113-2022-00102
• Device Sequence Number: 12722288
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)241130(10)E4193342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2022
• Report Date (Section F): 09/23/2022

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: 11/30/2024
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E4193342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2022
• Date Device Manufactured: 11/30/2021
• 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
• Patient Sex: Unknown