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

Model Number G21360

Device Problem Difficult to Remove (1528)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.A supplemental report will be provided upon conclusion.(b)(4).

Event Description

It is alleged that [pt] received a gunther tulip filter on (b)(6) 2015.This additional information received on april 27, 2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the right femoral vein due to left common femoral vein deep vein thrombosis (dvt) and pulmonary embolism (pe).Plaintiff is alleging device is unable to be retrieved and bleeding.Additional information provided determined that this device was manufactured by cook inc.

Manufacturer Narrative

Corrected from adverse event to adverse event and product problem.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, "tulip, device is unable to be retrieved, bleeding." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if the reported device is unable to be retrieved and bleeding is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.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.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6587053
• MDR Text Key: 75826687
• Report Number: 1820334-2017-01250
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)160901(10)5355164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G21360
• Device Catalogue Number: IGTCFS-65-UNI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Date Device Manufactured: 10/16/2014
• 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): Life Threatening
• Patient Weight: 87