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

Model Number G33016

Device Problem Difficult to Remove (1528)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

The previous mdr was submitted by (former manufacturer) under manufacturer report reference# 3002808486-2018-00279.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc.Informs that all future submissions regarding this complaint will be handled under this manufacturer report reference #.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Patient allegedly received an implant on (b)(6) 2014 due to deep vein thrombosis and/or pulmonary embolism.Patient is alleging device is unable to be retrieved.Patient further alleges pain and respiratory distress.Additionally it is alleged that there was an attempted ivc filter removal on (b)(6) 2016.

Manufacturer Narrative

Correction: this report is being submitted retrospectively per fda request.The information in this report was previously submitted on 06nov2018 on a report with an incorrect follow up # 5.Therefore, this report is being submitted as a correction follow up # 1.Additional information: investigation ¿ it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'gunther tulip - unable to retrieve, pain, respiratory distress'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported pain and respiratory discomfort are directly related to the filter.No relevant notes on neither device or lot number.No other complaints on lot.Product is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.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 provided at this time.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7966197
• MDR Text Key: 123807295
• Report Number: 1820334-2018-03178
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)161001(10)4613650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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: 10/01/2016
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 4613650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Sex: Female