MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sepsis (2067); Thrombosis (2100); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.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

'it is alleged that "[pt] received a cook celect filter on (b)(6) 2011".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported sepsis, blood clots and pain are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right external jugular vein due to deep vein thrombosis (dvt).Patient is alleging "sepsis, blood clots, possibilities of starting on blood thinner, pain on right clavicle area and partial left side".Per the (b)(6) 2011 inferior vena cava filter placement: "impression successful right external jugular placement of a inferior vena cava filter".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8763679
• MDR Text Key: 150109683
• Report Number: 3002808486-2019-00922
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening