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

Catalog Number IGTCFS-65-FEM

Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Chest Pain (1776); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a gunther tulip filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057 mfr date: unknown as lot# is unknown.(b)(4).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a gunther tulip filter.Expiration date: unknown as lot # is unknown.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.Mfr date unknown as lot# is unknown.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Additional information provided determined that this device was manufactured by (b)(4) with the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.

Event Description

This additional information received on 02/09/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2012 via the right femoral vein due to high risk of dvt and pe associated with bariatric surgery.Plaintiff alleges attempted retrieval on (b)(6) 2012.Plaintiff is alleging tilt, device unable to be retrieved, chest pain, shortness of breath.Additional information provided determined that this device was manufactured by with the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.

• 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 Contact: marianne hoey ; sandet 6; bjaeverskov 4632 4632 ; DA 4632 ; 5685686868
• MDR Report Key: 6208727
• MDR Text Key: 63406795
• Report Number: 3002808486-2016-01545
• Device Sequence Number: 1
• Product Code: DTK
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2017; 05/11/2017
• Date Device Manufactured: 03/16/2010
• 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; Other
• Patient Weight: 76