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

Model Number	G52916
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510k: similar to device marketed under pma/510(k): k211874.Summary of investigational findings: the physician suspected that the filter catheter might have advanced into another blood vessel than ivc, so the physician stopped deploying.The physician pulled back the filter catheter into the sheath with force and when the physician attempted to remove the sheath out of the patient the filter dropped off and the filter flowed into the right atrium.The physician managed to retrieve the filter from the right atrium using a snare and a guiding sheath.It was assessed that because no non-conformances were detected, 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.The ifu warns that excessive force should not be exerted to reposition or retrieve the filter, as it may lead to filter breakage and/or harm to the patient.There are adequate controls in place to ensure the device was manufactured to specifications.No device or images were provided for the investigation.With the information provided an exact cause cannot be determined.However, it was reported that the physician attempted to pull back the jugular introducer with filter inside the introducer sheath with force.This could have contributed to the filter falling off when the physician would remove the device from the patient due to the grasping hook on the jugular introducer had been pulled out of shape and made it impossible to hold on to the filter, but this is purely speculations.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
Description of event according to initial reporter: after inserting the filter catheter into the sheath, the user attempted to deploy the filter but there was a possibility that the filter catheter might have advanced in the blood vessel other than ivc so he stopped deploying.He attempted to pull back the filter catheter in to the sheath forcedly, filter was stayed off at the tip of the sheath.When he attempted to remove the sheath out of the patient's body, the filter dropped off and flowed in the right atrium.He managed to retrieve the filter from the right atrium using a snare and a guiding sheath.Patient outcome: no health hazard.

• Brand Name: GUNTHER TULIP 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: 16749702
• Report Number: 3002808486-2023-00091
• Device Sequence Number: 16985636
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)251115(10)E4333344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: 11/15/2025
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4333344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown