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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Aspiration/Inhalation (1725); Stenosis (2263); No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation.

 
Event Description

It is alleged the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6) health system in (b)(6). It is alleged the patient was injured without further explanation. Patient is also seeing punitive damages. Medical records were requested, but have yet to be provided.

 
Manufacturer Narrative

(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.

 
Event Description

It is alleged the patient received a gunther tulip filter on (b)(6) 2008 at (b)(6) health system in (b)(6). It is alleged the patient was injured without further explanation. Medical records were requested, but have yet to be provided.

 
Manufacturer Narrative

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

 
Event Description

This additional information was received on 03/20/2017 as follows: the patient allegedly received the device implant via right internal jugular vein on (b)(6) 2008. The patient is alleging device tilt and shortness of breath.

 
Manufacturer Narrative

Product lot number. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "tilt and shortness of breath". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. 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.

 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8123392235
MDR Report Key6060167
MDR Text Key58502420
Report Number1820334-2016-01203
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 CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2010
Device MODEL NumberN/A
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number1838104
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 Received10/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2007
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: 10/27/2016 Patient Sequence Number: 1
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