MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problem Device Tipped Over (2589)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Only the filter is similar to other gunther tulip filters marketed under pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the gunther tulip filter was placed (b)(6) 2021.On (b)(6) 2021, retrieving the filter was performed.The access was gained from the right jugular vein.The physician tried to collect the gunther using the reported device, but the snare became unable to open after several times of snare deployment.The gunther tulip filter, which was to difficult to be retrieved, was tilted a little bit, and its hook was embedded in the vascular wall leading the filter not to be caught by the snare.Therefore, another gtrs-200-rb was used instead.However, retrieving the filter was failed, so the user will retry at a later date.Additional information received 21sep2021: regarding the meaning of "failure" of, the second gtrs also could not retrieve the filter because the gunther, which was to difficult to be retrieved, was tilted a little bit, and its hook was embedded in the vascular wall leading the filter not to be caught by the snare.The next retrieval attempt will be 11oct2021.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the filter was tilted and embedded ((b)(4)) and the snare became unable to open after several times of snare deployment ((b)(4)) the filter was to be retrieved approx.One month later.The tulip filter was not returned and images could not be obtained.Consequently, based on the information provided it would be inappropriate to speculate at what may or may not have caused the filter to tilt and to embed during an approx.Two months dwell time.Potential causes of filter tilt may include filter placement in ivc vessels with internal diameters larger than 30mm; improper deployment; surgical or endovascular procedures performed near an implanted filter; and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval, vena cava wall perforation, or result in loss of filter efficiency.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final release, there is evidence that the dhr was fully executed.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: 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 ; 56868686
• MDR Report Key: 12538932
• MDR Text Key: 273542470
• Report Number: 3002808486-2021-01837
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002037738
• UDI-Public: (01)10827002037738(17)230915(10)E4018633
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Device Lot Number: E4018633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention