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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog # unknown as information was not provided but referred to as either gunther tulip mreye, gunther tulip vena cava filter, cook celect vena cava filter, or cook celect platinum.Lot# unknown as information was not provided.Expiration date unknown as lot# is unknown.As catalog# is unknown it could be either k000855, k032426, k061815, k073374, k090140, k112119, k121057 or k121629.Investigation is still in progress.

Event Description

Description according to complaint filed: it is alleged that "[pt] received an ivc filter" patient outcome: it is alleged "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] have suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost ability to live a normal life, and will continue to be so diminished into the future." hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Patient code: (b)(4).Device code: (b)(4).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.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.

• 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: 5366213
• MDR Text Key: 35923455
• Report Number: 3002808486-2016-00015
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/05/2016
• Date Manufacturer Received: 01/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening