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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Aspiration/Inhalation (1725); Chest Pain (1776); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable. The event is currently under investigation.

 
Event Description

It is alleged, "the [patient] received a gunther tulip filter on (b)(6) 2007 at (b)(6) hospital in (b)(6). " it is alleged that the patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

Describe event or problem) please see updated/corrected information. Patient and device code: no information regarding the event has been provided. 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 the [patient] received a gunther tulip filter on (b)(6) 2007 at (b)(6). It is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
Manufacturer Narrative

(b)(4). The 510(k): k032426. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

Additional information received 2/22/17: patient alleges that ivc filter was implanted (b)(6) 2007. Filter was implanted about 4 months after 2/3's of her left lung removed due to lung cancer. No attempts have been made to retrieve the filter. Patient suffers from chest pain and shortness of breath.

 
Manufacturer Narrative

According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e. G. , the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu. It has not been possible to fully investigate or evaluate this 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.

 
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Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6222794
MDR Text Key63864239
Report Number1820334-2017-00019
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup
Report Date 06/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/05/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/04/2017 Patient Sequence Number: 1
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