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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Pain (1994); Palpitations (2467); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.(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

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2007.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.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

Patient allegedly received an implant on (b)(6) 2007 via the internal jugular vein due to recurrent deep vein thrombosis, being allergic to coumadin, h/o coagulopathy.Patient alleges supraventricular tachycardia, fluctuating blood pressure, palpitation, confusion, nausea, fatigue, shortness of breath.Patient further alleges palpitations, chest pain, abnormal ecgs (svts & afib/flutters), fear.

Manufacturer Narrative

Investigation: 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 tachycardia, fluctuating blood pressure(bp), confusion, nausea, fatigue, pain, heart flutter/palpitation, fear, and shortness of breath(sob) are directly related to the filter and unable to identify a corresponding failure mode at this time.The following allegations have been investigated: tachycardia, fluctuating bp, confusion, nausea, fatigue, pain, heart flutter/palpitation, fear, sob.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 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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL; sandet 6, dk-4632; bjaeverskov DK-46 32; DA DK-4632
• MDR Report Key: 8343564
• MDR Text Key: 136267423
• Report Number: 1820334-2019-00468
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84